Clinical Trials Unit
Stanford University School of Medicine's Center for Advanced Dermatologic Investigation is the Dermatology Department's clinical trials unit.
The Center is home to 12-15 ongoing clinical studies, investigating the safety and efficacy of new and currently available drugs and over-the-counter medications. The Center works with Stanford's own panel on medical research, leading pharmaceutical companies,and the Food and Drug Administration to safely and ethically expand the medical field's knowledge of dermatologic treatments. New studies begin regularly, and the Center continues to recruit patients with skin aging, sun damage, skin cancer (including basal cell carcinomas), psoriasis, atopic dermatitis, rosacea, and other dermatologic diseases for ongoing studies.
Skin Aging Studies
We seek to understand the human aging processes as it relates to skin on a fundamental level. To this end, our studies focus on clinical and translational research efforts ranging from: (1) the analysis of gene changes which predispose individuals to exceptionally youthful skin to (2) molecular signatures that may be biomarkers for aging skin to (3) the careful study of new candidate agents which might affect the skin aging process.
Nonmelanoma Skin Cancer
Recent advances in our understanding of basal cell skin cancer biology have enabled the development of cutting edge study drugs which combat tumor growth. We are currently home to a number of clinical trials at the forefront of potential therapy for advanced or metastatic basal cell cancer. In addition, we seek to understand the biology of basal cell skin cancers and to identify molecular predictors for treatment success.
Acne Rosecea
This is a common and frustrating chronic inflammatory condition of the face, usually affecting older individuals. The causes of this complex condition are the subject of much study. Our clinical studies seek to identify new topical or oral medications to improve the symptoms of acne rosacea.
Contact
For more information, please email dermtrials@stanford.edu
Featured Clinical Trials
Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial
The objective of the PORTICO pivotal IDE trial is to evaluate the safety and effectiveness of the St Jude Medical (SJM) Portico Transcatheter Heart Valve and Delivery Systems (Portico) in the treatment of severe symptomatic aortic stenosis via transfemoral and alternative delivery methods in high risk and extreme risk patients.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- device: Portico transcatheter aortic valve
- device: Commercially available transcatheter aortic valve
Eligibility
Inclusion Criteria
1. Subjects must have co-morbidities such that the surgeon and cardiologist
Co-Investigators concur that the predicted risk of operative mortality is ≥15% or a
minimum Society of Thoracic Surgeons (STS) score of 8%. A candidate who does not meet
the STS score criteria of ≥ 8% can be included in the study if a peer review by at
least two surgeons concludes and documents that the patient's predicted risk of
operative mortality is ≥15%. The surgeon's assessment of operative comorbidities not
captured by the STS score must be documented in the study case report form as well as
in the patient medical record.
2. Subject is 21 years of age or older at the time of consent.
3. Subject has senile degenerative aortic valve stenosis with echocardiographically
derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s or
Doppler Velocity Index <0.25 and an initial aortic valve area (AVA) of ≤ 1.0 cm2
(indexed effective orifice area (EOA) ≤ 0.6 cm2/m2). (Qualifying AVA baseline
measurement must be within 60 days prior to informed consent).
4. Subject has symptomatic aortic stenosis as demonstrated by New York Heart Association
(NYHA) Functional Classification of II, III, or IV.
5. The subject has been informed of the nature of the study, agrees to its provisions and
has provided written informed consent as approved by the Institutional Review Board
(IRB) of the respective clinical site.
6. The subject and the treating physician agree that the subject will return for all
required post-procedure follow-up visits.
7. Subject's aortic annulus is 19-27mm diameter as measured by computerized tomography
(CT) conducted within 12 months prior to informed consent. Note: if CT is
contraindicated and/or not possible to be obtained for certain subjects, a 3D echo and
non-contrast CT of chest and abdomen/pelvis may be accepted if approved by the subject
selection committee.
For a subject to be considered an Extreme Risk candidate they must meet # 2, 3, 4, 5,
6, 7 of the above criteria, and
8. The subject, after formal consults by a cardiologist and two cardiovascular surgeons
agree that medical factors preclude operation, based on a conclusion that the
probability of death or serious, irreversible morbidity exceeds the probability of
meaningful improvement. Specifically, the probability of death or serious,
irreversible morbidity should exceed 50%. The surgeons' consult notes shall specify
the medical or anatomic factors leading to that conclusion and include a printout of
the calculation of the STS score to additionally identify the risks in these patients.
Exclusion Criteria
1. Evidence of an acute myocardial infarction (defined as: ST Segment Elevation as
evidenced on 12 Lead ECG) within 30 days prior to index procedure.
2. Aortic valve is a congenital unicuspid or congenital bicuspid valve or is
non-calcified as verified by echocardiography.
3. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant
aortic regurgitation 3-4+).
4. Any percutaneous coronary or peripheral interventional procedure performed within 30
days prior to index procedure.
5. Pre-existing prosthetic heart valve or other implant in any valve position, prosthetic
ring, severe circumferential mitral annular calcification (MAC) which is continuous
with calcium in the left ventricular outflow tract (LVOT), severe (greater than 3+)
mitral insufficiency, or severe mitral stenosis with pulmonary compromise. Subjects
with pre-existing surgical bioprosthetic aortic heart valve should be considered for
the Valve-in-Valve registry.
6. Blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb < 9 g/dL),
thrombocytopenia (platelet count <50,000 cells/mm³).
7. History of bleeding diathesis or coagulopathy.
8. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or
mechanical hemodynamic support.
9. Untreated clinically significant coronary artery disease requiring revascularization.
10. Hemodynamic instability requiring inotropic support or mechanical heart assistance.
11. Need for emergency surgery for any reason.
12. Hypertrophic cardiomyopathy with or without obstruction (HOCM).
13. Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% as
measured by resting echocardiogram.
14. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
15. Active peptic ulcer or upper gastrointestinal (GI) bleeding within 3 months prior to
index procedure.
16. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine
(Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media which cannot be
adequately premedicated.
17. Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA)
or a transient ischemic attack (TIA).
18. Renal insufficiency (creatinine > 3.0 mg/dL) and/or end stage renal disease requiring
chronic dialysis.
19. Life expectancy < 12 months from the time of informed consent due to non-cardiac
co-morbid conditions.
20. Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as
maximal luminal diameter 5cm or greater; marked tortuosity (hyperacute bend), aortic
arch atheroma (especially if thick [> 5 mm], protruding or ulcerated) or narrowing
(especially with calcification and surface irregularities) of the abdominal or
thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta (applicable
for transfemoral patients only).
21. Native aortic annulus size < 19 mm or > 27 mm per the baseline diagnostic imaging.
22. Aortic root angulation > 70° (applicable for transfemoral patients only).
23. Currently participating in an investigational drug or device study.
24. Active bacterial endocarditis within 6 months prior to the index procedure.
25. Bulky calcified aortic valve leaflets in close proximity to coronary ostia.
26. Non-calcified aortic annulus
27. Iliofemoral vessel characteristics that would preclude safe placement of the
introducer sheath such as severe obstructive calcification, or severe tortuosity
(applicable for transfemoral patients only).
Additional Exclusion Criteria (Transcatheter Access Related)
For selection of an appropriate alternative access delivery method, subjects were screened
using the following access specific exclusion criteria:
Transaortic (TAo) Subject Cohort Specific Exclusion Criteria
1. Subject has pre-existing patent RIMA graft that would preclude access.
2. Subject has a hostile chest or other condition that complicates transaortic access.
3. Subject has a porcelain aorta, defined as an extensive circumferential calcification
of the ascending aorta that would complicate TAo access.
Additional exclusion criteria for transaortic access using the FlexNav™ Delivery System:
1. Subject has a distance between the annular plane and the aortic access site <7 cm
(2.8")
2. Subject has a distance between the annular plane and the separate introducer sheath
distal tip <6 cm (2.4")
Subclavian/Axillary Subject Cohort Specific Exclusion Criteria
1. Subject's access vessel (subclavian/axillary) diameter will not allow for introduction
of the applicable 18 Fr or 19 Fr delivery system.
2. Subject's subclavian/axillary arteries have severe calcification and/or tortuosity.
3. Subject's aortic root angulation is:
- Left Subclavian/Left Axillary: >70◦
- Right Subclavian/Right Axillary: >30◦
4. Subject has a history of patent LIMA/RIMA graft that would preclude access
Additional exclusion criteria for subclavian/axillary access using the FlexNav™ Delivery
System:
1. Subject's access vessel (subclavian/axillary) has a distance between the annular plane
and the integrated sheath distal tip <17 cm (6.7")
2. Subject's access vessel requires the delivery system to be advanced through a separate
introducer sheath
Ages Eligible for Study
21 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Recruiting
Psoriasis Clinical Trials
Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial
The objective of the PORTICO pivotal IDE trial is to evaluate the safety and effectiveness of the St Jude Medical (SJM) Portico Transcatheter Heart Valve and Delivery Systems (Portico) in the treatment of severe symptomatic aortic stenosis via transfemoral and alternative delivery methods in high risk and extreme risk patients.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- device: Portico transcatheter aortic valve
- device: Commercially available transcatheter aortic valve
Eligibility
Inclusion Criteria
1. Subjects must have co-morbidities such that the surgeon and cardiologist
Co-Investigators concur that the predicted risk of operative mortality is ≥15% or a
minimum Society of Thoracic Surgeons (STS) score of 8%. A candidate who does not meet
the STS score criteria of ≥ 8% can be included in the study if a peer review by at
least two surgeons concludes and documents that the patient's predicted risk of
operative mortality is ≥15%. The surgeon's assessment of operative comorbidities not
captured by the STS score must be documented in the study case report form as well as
in the patient medical record.
2. Subject is 21 years of age or older at the time of consent.
3. Subject has senile degenerative aortic valve stenosis with echocardiographically
derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s or
Doppler Velocity Index <0.25 and an initial aortic valve area (AVA) of ≤ 1.0 cm2
(indexed effective orifice area (EOA) ≤ 0.6 cm2/m2). (Qualifying AVA baseline
measurement must be within 60 days prior to informed consent).
4. Subject has symptomatic aortic stenosis as demonstrated by New York Heart Association
(NYHA) Functional Classification of II, III, or IV.
5. The subject has been informed of the nature of the study, agrees to its provisions and
has provided written informed consent as approved by the Institutional Review Board
(IRB) of the respective clinical site.
6. The subject and the treating physician agree that the subject will return for all
required post-procedure follow-up visits.
7. Subject's aortic annulus is 19-27mm diameter as measured by computerized tomography
(CT) conducted within 12 months prior to informed consent. Note: if CT is
contraindicated and/or not possible to be obtained for certain subjects, a 3D echo and
non-contrast CT of chest and abdomen/pelvis may be accepted if approved by the subject
selection committee.
For a subject to be considered an Extreme Risk candidate they must meet # 2, 3, 4, 5,
6, 7 of the above criteria, and
8. The subject, after formal consults by a cardiologist and two cardiovascular surgeons
agree that medical factors preclude operation, based on a conclusion that the
probability of death or serious, irreversible morbidity exceeds the probability of
meaningful improvement. Specifically, the probability of death or serious,
irreversible morbidity should exceed 50%. The surgeons' consult notes shall specify
the medical or anatomic factors leading to that conclusion and include a printout of
the calculation of the STS score to additionally identify the risks in these patients.
Exclusion Criteria
1. Evidence of an acute myocardial infarction (defined as: ST Segment Elevation as
evidenced on 12 Lead ECG) within 30 days prior to index procedure.
2. Aortic valve is a congenital unicuspid or congenital bicuspid valve or is
non-calcified as verified by echocardiography.
3. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant
aortic regurgitation 3-4+).
4. Any percutaneous coronary or peripheral interventional procedure performed within 30
days prior to index procedure.
5. Pre-existing prosthetic heart valve or other implant in any valve position, prosthetic
ring, severe circumferential mitral annular calcification (MAC) which is continuous
with calcium in the left ventricular outflow tract (LVOT), severe (greater than 3+)
mitral insufficiency, or severe mitral stenosis with pulmonary compromise. Subjects
with pre-existing surgical bioprosthetic aortic heart valve should be considered for
the Valve-in-Valve registry.
6. Blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb < 9 g/dL),
thrombocytopenia (platelet count <50,000 cells/mm³).
7. History of bleeding diathesis or coagulopathy.
8. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or
mechanical hemodynamic support.
9. Untreated clinically significant coronary artery disease requiring revascularization.
10. Hemodynamic instability requiring inotropic support or mechanical heart assistance.
11. Need for emergency surgery for any reason.
12. Hypertrophic cardiomyopathy with or without obstruction (HOCM).
13. Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% as
measured by resting echocardiogram.
14. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
15. Active peptic ulcer or upper gastrointestinal (GI) bleeding within 3 months prior to
index procedure.
16. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine
(Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media which cannot be
adequately premedicated.
17. Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA)
or a transient ischemic attack (TIA).
18. Renal insufficiency (creatinine > 3.0 mg/dL) and/or end stage renal disease requiring
chronic dialysis.
19. Life expectancy < 12 months from the time of informed consent due to non-cardiac
co-morbid conditions.
20. Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as
maximal luminal diameter 5cm or greater; marked tortuosity (hyperacute bend), aortic
arch atheroma (especially if thick [> 5 mm], protruding or ulcerated) or narrowing
(especially with calcification and surface irregularities) of the abdominal or
thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta (applicable
for transfemoral patients only).
21. Native aortic annulus size < 19 mm or > 27 mm per the baseline diagnostic imaging.
22. Aortic root angulation > 70° (applicable for transfemoral patients only).
23. Currently participating in an investigational drug or device study.
24. Active bacterial endocarditis within 6 months prior to the index procedure.
25. Bulky calcified aortic valve leaflets in close proximity to coronary ostia.
26. Non-calcified aortic annulus
27. Iliofemoral vessel characteristics that would preclude safe placement of the
introducer sheath such as severe obstructive calcification, or severe tortuosity
(applicable for transfemoral patients only).
Additional Exclusion Criteria (Transcatheter Access Related)
For selection of an appropriate alternative access delivery method, subjects were screened
using the following access specific exclusion criteria:
Transaortic (TAo) Subject Cohort Specific Exclusion Criteria
1. Subject has pre-existing patent RIMA graft that would preclude access.
2. Subject has a hostile chest or other condition that complicates transaortic access.
3. Subject has a porcelain aorta, defined as an extensive circumferential calcification
of the ascending aorta that would complicate TAo access.
Additional exclusion criteria for transaortic access using the FlexNav™ Delivery System:
1. Subject has a distance between the annular plane and the aortic access site <7 cm
(2.8")
2. Subject has a distance between the annular plane and the separate introducer sheath
distal tip <6 cm (2.4")
Subclavian/Axillary Subject Cohort Specific Exclusion Criteria
1. Subject's access vessel (subclavian/axillary) diameter will not allow for introduction
of the applicable 18 Fr or 19 Fr delivery system.
2. Subject's subclavian/axillary arteries have severe calcification and/or tortuosity.
3. Subject's aortic root angulation is:
- Left Subclavian/Left Axillary: >70◦
- Right Subclavian/Right Axillary: >30◦
4. Subject has a history of patent LIMA/RIMA graft that would preclude access
Additional exclusion criteria for subclavian/axillary access using the FlexNav™ Delivery
System:
1. Subject's access vessel (subclavian/axillary) has a distance between the annular plane
and the integrated sheath distal tip <17 cm (6.7")
2. Subject's access vessel requires the delivery system to be advanced through a separate
introducer sheath
Ages Eligible for Study
21 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Recruiting
Dermatology Clinical Trials
Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial
The objective of the PORTICO pivotal IDE trial is to evaluate the safety and effectiveness of the St Jude Medical (SJM) Portico Transcatheter Heart Valve and Delivery Systems (Portico) in the treatment of severe symptomatic aortic stenosis via transfemoral and alternative delivery methods in high risk and extreme risk patients.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- device: Portico transcatheter aortic valve
- device: Commercially available transcatheter aortic valve
Eligibility
Inclusion Criteria
1. Subjects must have co-morbidities such that the surgeon and cardiologist
Co-Investigators concur that the predicted risk of operative mortality is ≥15% or a
minimum Society of Thoracic Surgeons (STS) score of 8%. A candidate who does not meet
the STS score criteria of ≥ 8% can be included in the study if a peer review by at
least two surgeons concludes and documents that the patient's predicted risk of
operative mortality is ≥15%. The surgeon's assessment of operative comorbidities not
captured by the STS score must be documented in the study case report form as well as
in the patient medical record.
2. Subject is 21 years of age or older at the time of consent.
3. Subject has senile degenerative aortic valve stenosis with echocardiographically
derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s or
Doppler Velocity Index <0.25 and an initial aortic valve area (AVA) of ≤ 1.0 cm2
(indexed effective orifice area (EOA) ≤ 0.6 cm2/m2). (Qualifying AVA baseline
measurement must be within 60 days prior to informed consent).
4. Subject has symptomatic aortic stenosis as demonstrated by New York Heart Association
(NYHA) Functional Classification of II, III, or IV.
5. The subject has been informed of the nature of the study, agrees to its provisions and
has provided written informed consent as approved by the Institutional Review Board
(IRB) of the respective clinical site.
6. The subject and the treating physician agree that the subject will return for all
required post-procedure follow-up visits.
7. Subject's aortic annulus is 19-27mm diameter as measured by computerized tomography
(CT) conducted within 12 months prior to informed consent. Note: if CT is
contraindicated and/or not possible to be obtained for certain subjects, a 3D echo and
non-contrast CT of chest and abdomen/pelvis may be accepted if approved by the subject
selection committee.
For a subject to be considered an Extreme Risk candidate they must meet # 2, 3, 4, 5,
6, 7 of the above criteria, and
8. The subject, after formal consults by a cardiologist and two cardiovascular surgeons
agree that medical factors preclude operation, based on a conclusion that the
probability of death or serious, irreversible morbidity exceeds the probability of
meaningful improvement. Specifically, the probability of death or serious,
irreversible morbidity should exceed 50%. The surgeons' consult notes shall specify
the medical or anatomic factors leading to that conclusion and include a printout of
the calculation of the STS score to additionally identify the risks in these patients.
Exclusion Criteria
1. Evidence of an acute myocardial infarction (defined as: ST Segment Elevation as
evidenced on 12 Lead ECG) within 30 days prior to index procedure.
2. Aortic valve is a congenital unicuspid or congenital bicuspid valve or is
non-calcified as verified by echocardiography.
3. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant
aortic regurgitation 3-4+).
4. Any percutaneous coronary or peripheral interventional procedure performed within 30
days prior to index procedure.
5. Pre-existing prosthetic heart valve or other implant in any valve position, prosthetic
ring, severe circumferential mitral annular calcification (MAC) which is continuous
with calcium in the left ventricular outflow tract (LVOT), severe (greater than 3+)
mitral insufficiency, or severe mitral stenosis with pulmonary compromise. Subjects
with pre-existing surgical bioprosthetic aortic heart valve should be considered for
the Valve-in-Valve registry.
6. Blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb < 9 g/dL),
thrombocytopenia (platelet count <50,000 cells/mm³).
7. History of bleeding diathesis or coagulopathy.
8. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or
mechanical hemodynamic support.
9. Untreated clinically significant coronary artery disease requiring revascularization.
10. Hemodynamic instability requiring inotropic support or mechanical heart assistance.
11. Need for emergency surgery for any reason.
12. Hypertrophic cardiomyopathy with or without obstruction (HOCM).
13. Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% as
measured by resting echocardiogram.
14. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
15. Active peptic ulcer or upper gastrointestinal (GI) bleeding within 3 months prior to
index procedure.
16. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine
(Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media which cannot be
adequately premedicated.
17. Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA)
or a transient ischemic attack (TIA).
18. Renal insufficiency (creatinine > 3.0 mg/dL) and/or end stage renal disease requiring
chronic dialysis.
19. Life expectancy < 12 months from the time of informed consent due to non-cardiac
co-morbid conditions.
20. Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as
maximal luminal diameter 5cm or greater; marked tortuosity (hyperacute bend), aortic
arch atheroma (especially if thick [> 5 mm], protruding or ulcerated) or narrowing
(especially with calcification and surface irregularities) of the abdominal or
thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta (applicable
for transfemoral patients only).
21. Native aortic annulus size < 19 mm or > 27 mm per the baseline diagnostic imaging.
22. Aortic root angulation > 70° (applicable for transfemoral patients only).
23. Currently participating in an investigational drug or device study.
24. Active bacterial endocarditis within 6 months prior to the index procedure.
25. Bulky calcified aortic valve leaflets in close proximity to coronary ostia.
26. Non-calcified aortic annulus
27. Iliofemoral vessel characteristics that would preclude safe placement of the
introducer sheath such as severe obstructive calcification, or severe tortuosity
(applicable for transfemoral patients only).
Additional Exclusion Criteria (Transcatheter Access Related)
For selection of an appropriate alternative access delivery method, subjects were screened
using the following access specific exclusion criteria:
Transaortic (TAo) Subject Cohort Specific Exclusion Criteria
1. Subject has pre-existing patent RIMA graft that would preclude access.
2. Subject has a hostile chest or other condition that complicates transaortic access.
3. Subject has a porcelain aorta, defined as an extensive circumferential calcification
of the ascending aorta that would complicate TAo access.
Additional exclusion criteria for transaortic access using the FlexNav™ Delivery System:
1. Subject has a distance between the annular plane and the aortic access site <7 cm
(2.8")
2. Subject has a distance between the annular plane and the separate introducer sheath
distal tip <6 cm (2.4")
Subclavian/Axillary Subject Cohort Specific Exclusion Criteria
1. Subject's access vessel (subclavian/axillary) diameter will not allow for introduction
of the applicable 18 Fr or 19 Fr delivery system.
2. Subject's subclavian/axillary arteries have severe calcification and/or tortuosity.
3. Subject's aortic root angulation is:
- Left Subclavian/Left Axillary: >70◦
- Right Subclavian/Right Axillary: >30◦
4. Subject has a history of patent LIMA/RIMA graft that would preclude access
Additional exclusion criteria for subclavian/axillary access using the FlexNav™ Delivery
System:
1. Subject's access vessel (subclavian/axillary) has a distance between the annular plane
and the integrated sheath distal tip <17 cm (6.7")
2. Subject's access vessel requires the delivery system to be advanced through a separate
introducer sheath
Ages Eligible for Study
21 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Recruiting
Pediatric Dermatology Clinical Trials
Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial
The objective of the PORTICO pivotal IDE trial is to evaluate the safety and effectiveness of the St Jude Medical (SJM) Portico Transcatheter Heart Valve and Delivery Systems (Portico) in the treatment of severe symptomatic aortic stenosis via transfemoral and alternative delivery methods in high risk and extreme risk patients.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- device: Portico transcatheter aortic valve
- device: Commercially available transcatheter aortic valve
Eligibility
Inclusion Criteria
1. Subjects must have co-morbidities such that the surgeon and cardiologist
Co-Investigators concur that the predicted risk of operative mortality is ≥15% or a
minimum Society of Thoracic Surgeons (STS) score of 8%. A candidate who does not meet
the STS score criteria of ≥ 8% can be included in the study if a peer review by at
least two surgeons concludes and documents that the patient's predicted risk of
operative mortality is ≥15%. The surgeon's assessment of operative comorbidities not
captured by the STS score must be documented in the study case report form as well as
in the patient medical record.
2. Subject is 21 years of age or older at the time of consent.
3. Subject has senile degenerative aortic valve stenosis with echocardiographically
derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s or
Doppler Velocity Index <0.25 and an initial aortic valve area (AVA) of ≤ 1.0 cm2
(indexed effective orifice area (EOA) ≤ 0.6 cm2/m2). (Qualifying AVA baseline
measurement must be within 60 days prior to informed consent).
4. Subject has symptomatic aortic stenosis as demonstrated by New York Heart Association
(NYHA) Functional Classification of II, III, or IV.
5. The subject has been informed of the nature of the study, agrees to its provisions and
has provided written informed consent as approved by the Institutional Review Board
(IRB) of the respective clinical site.
6. The subject and the treating physician agree that the subject will return for all
required post-procedure follow-up visits.
7. Subject's aortic annulus is 19-27mm diameter as measured by computerized tomography
(CT) conducted within 12 months prior to informed consent. Note: if CT is
contraindicated and/or not possible to be obtained for certain subjects, a 3D echo and
non-contrast CT of chest and abdomen/pelvis may be accepted if approved by the subject
selection committee.
For a subject to be considered an Extreme Risk candidate they must meet # 2, 3, 4, 5,
6, 7 of the above criteria, and
8. The subject, after formal consults by a cardiologist and two cardiovascular surgeons
agree that medical factors preclude operation, based on a conclusion that the
probability of death or serious, irreversible morbidity exceeds the probability of
meaningful improvement. Specifically, the probability of death or serious,
irreversible morbidity should exceed 50%. The surgeons' consult notes shall specify
the medical or anatomic factors leading to that conclusion and include a printout of
the calculation of the STS score to additionally identify the risks in these patients.
Exclusion Criteria
1. Evidence of an acute myocardial infarction (defined as: ST Segment Elevation as
evidenced on 12 Lead ECG) within 30 days prior to index procedure.
2. Aortic valve is a congenital unicuspid or congenital bicuspid valve or is
non-calcified as verified by echocardiography.
3. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant
aortic regurgitation 3-4+).
4. Any percutaneous coronary or peripheral interventional procedure performed within 30
days prior to index procedure.
5. Pre-existing prosthetic heart valve or other implant in any valve position, prosthetic
ring, severe circumferential mitral annular calcification (MAC) which is continuous
with calcium in the left ventricular outflow tract (LVOT), severe (greater than 3+)
mitral insufficiency, or severe mitral stenosis with pulmonary compromise. Subjects
with pre-existing surgical bioprosthetic aortic heart valve should be considered for
the Valve-in-Valve registry.
6. Blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb < 9 g/dL),
thrombocytopenia (platelet count <50,000 cells/mm³).
7. History of bleeding diathesis or coagulopathy.
8. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or
mechanical hemodynamic support.
9. Untreated clinically significant coronary artery disease requiring revascularization.
10. Hemodynamic instability requiring inotropic support or mechanical heart assistance.
11. Need for emergency surgery for any reason.
12. Hypertrophic cardiomyopathy with or without obstruction (HOCM).
13. Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% as
measured by resting echocardiogram.
14. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
15. Active peptic ulcer or upper gastrointestinal (GI) bleeding within 3 months prior to
index procedure.
16. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine
(Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media which cannot be
adequately premedicated.
17. Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA)
or a transient ischemic attack (TIA).
18. Renal insufficiency (creatinine > 3.0 mg/dL) and/or end stage renal disease requiring
chronic dialysis.
19. Life expectancy < 12 months from the time of informed consent due to non-cardiac
co-morbid conditions.
20. Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as
maximal luminal diameter 5cm or greater; marked tortuosity (hyperacute bend), aortic
arch atheroma (especially if thick [> 5 mm], protruding or ulcerated) or narrowing
(especially with calcification and surface irregularities) of the abdominal or
thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta (applicable
for transfemoral patients only).
21. Native aortic annulus size < 19 mm or > 27 mm per the baseline diagnostic imaging.
22. Aortic root angulation > 70° (applicable for transfemoral patients only).
23. Currently participating in an investigational drug or device study.
24. Active bacterial endocarditis within 6 months prior to the index procedure.
25. Bulky calcified aortic valve leaflets in close proximity to coronary ostia.
26. Non-calcified aortic annulus
27. Iliofemoral vessel characteristics that would preclude safe placement of the
introducer sheath such as severe obstructive calcification, or severe tortuosity
(applicable for transfemoral patients only).
Additional Exclusion Criteria (Transcatheter Access Related)
For selection of an appropriate alternative access delivery method, subjects were screened
using the following access specific exclusion criteria:
Transaortic (TAo) Subject Cohort Specific Exclusion Criteria
1. Subject has pre-existing patent RIMA graft that would preclude access.
2. Subject has a hostile chest or other condition that complicates transaortic access.
3. Subject has a porcelain aorta, defined as an extensive circumferential calcification
of the ascending aorta that would complicate TAo access.
Additional exclusion criteria for transaortic access using the FlexNav™ Delivery System:
1. Subject has a distance between the annular plane and the aortic access site <7 cm
(2.8")
2. Subject has a distance between the annular plane and the separate introducer sheath
distal tip <6 cm (2.4")
Subclavian/Axillary Subject Cohort Specific Exclusion Criteria
1. Subject's access vessel (subclavian/axillary) diameter will not allow for introduction
of the applicable 18 Fr or 19 Fr delivery system.
2. Subject's subclavian/axillary arteries have severe calcification and/or tortuosity.
3. Subject's aortic root angulation is:
- Left Subclavian/Left Axillary: >70◦
- Right Subclavian/Right Axillary: >30◦
4. Subject has a history of patent LIMA/RIMA graft that would preclude access
Additional exclusion criteria for subclavian/axillary access using the FlexNav™ Delivery
System:
1. Subject's access vessel (subclavian/axillary) has a distance between the annular plane
and the integrated sheath distal tip <17 cm (6.7")
2. Subject's access vessel requires the delivery system to be advanced through a separate
introducer sheath
Ages Eligible for Study
21 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Recruiting
Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial
The objective of the PORTICO pivotal IDE trial is to evaluate the safety and effectiveness of the St Jude Medical (SJM) Portico Transcatheter Heart Valve and Delivery Systems (Portico) in the treatment of severe symptomatic aortic stenosis via transfemoral and alternative delivery methods in high risk and extreme risk patients.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- device: Portico transcatheter aortic valve
- device: Commercially available transcatheter aortic valve
Eligibility
Inclusion Criteria
1. Subjects must have co-morbidities such that the surgeon and cardiologist
Co-Investigators concur that the predicted risk of operative mortality is ≥15% or a
minimum Society of Thoracic Surgeons (STS) score of 8%. A candidate who does not meet
the STS score criteria of ≥ 8% can be included in the study if a peer review by at
least two surgeons concludes and documents that the patient's predicted risk of
operative mortality is ≥15%. The surgeon's assessment of operative comorbidities not
captured by the STS score must be documented in the study case report form as well as
in the patient medical record.
2. Subject is 21 years of age or older at the time of consent.
3. Subject has senile degenerative aortic valve stenosis with echocardiographically
derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s or
Doppler Velocity Index <0.25 and an initial aortic valve area (AVA) of ≤ 1.0 cm2
(indexed effective orifice area (EOA) ≤ 0.6 cm2/m2). (Qualifying AVA baseline
measurement must be within 60 days prior to informed consent).
4. Subject has symptomatic aortic stenosis as demonstrated by New York Heart Association
(NYHA) Functional Classification of II, III, or IV.
5. The subject has been informed of the nature of the study, agrees to its provisions and
has provided written informed consent as approved by the Institutional Review Board
(IRB) of the respective clinical site.
6. The subject and the treating physician agree that the subject will return for all
required post-procedure follow-up visits.
7. Subject's aortic annulus is 19-27mm diameter as measured by computerized tomography
(CT) conducted within 12 months prior to informed consent. Note: if CT is
contraindicated and/or not possible to be obtained for certain subjects, a 3D echo and
non-contrast CT of chest and abdomen/pelvis may be accepted if approved by the subject
selection committee.
For a subject to be considered an Extreme Risk candidate they must meet # 2, 3, 4, 5,
6, 7 of the above criteria, and
8. The subject, after formal consults by a cardiologist and two cardiovascular surgeons
agree that medical factors preclude operation, based on a conclusion that the
probability of death or serious, irreversible morbidity exceeds the probability of
meaningful improvement. Specifically, the probability of death or serious,
irreversible morbidity should exceed 50%. The surgeons' consult notes shall specify
the medical or anatomic factors leading to that conclusion and include a printout of
the calculation of the STS score to additionally identify the risks in these patients.
Exclusion Criteria
1. Evidence of an acute myocardial infarction (defined as: ST Segment Elevation as
evidenced on 12 Lead ECG) within 30 days prior to index procedure.
2. Aortic valve is a congenital unicuspid or congenital bicuspid valve or is
non-calcified as verified by echocardiography.
3. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant
aortic regurgitation 3-4+).
4. Any percutaneous coronary or peripheral interventional procedure performed within 30
days prior to index procedure.
5. Pre-existing prosthetic heart valve or other implant in any valve position, prosthetic
ring, severe circumferential mitral annular calcification (MAC) which is continuous
with calcium in the left ventricular outflow tract (LVOT), severe (greater than 3+)
mitral insufficiency, or severe mitral stenosis with pulmonary compromise. Subjects
with pre-existing surgical bioprosthetic aortic heart valve should be considered for
the Valve-in-Valve registry.
6. Blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb < 9 g/dL),
thrombocytopenia (platelet count <50,000 cells/mm³).
7. History of bleeding diathesis or coagulopathy.
8. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or
mechanical hemodynamic support.
9. Untreated clinically significant coronary artery disease requiring revascularization.
10. Hemodynamic instability requiring inotropic support or mechanical heart assistance.
11. Need for emergency surgery for any reason.
12. Hypertrophic cardiomyopathy with or without obstruction (HOCM).
13. Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% as
measured by resting echocardiogram.
14. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
15. Active peptic ulcer or upper gastrointestinal (GI) bleeding within 3 months prior to
index procedure.
16. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine
(Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media which cannot be
adequately premedicated.
17. Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA)
or a transient ischemic attack (TIA).
18. Renal insufficiency (creatinine > 3.0 mg/dL) and/or end stage renal disease requiring
chronic dialysis.
19. Life expectancy < 12 months from the time of informed consent due to non-cardiac
co-morbid conditions.
20. Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as
maximal luminal diameter 5cm or greater; marked tortuosity (hyperacute bend), aortic
arch atheroma (especially if thick [> 5 mm], protruding or ulcerated) or narrowing
(especially with calcification and surface irregularities) of the abdominal or
thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta (applicable
for transfemoral patients only).
21. Native aortic annulus size < 19 mm or > 27 mm per the baseline diagnostic imaging.
22. Aortic root angulation > 70° (applicable for transfemoral patients only).
23. Currently participating in an investigational drug or device study.
24. Active bacterial endocarditis within 6 months prior to the index procedure.
25. Bulky calcified aortic valve leaflets in close proximity to coronary ostia.
26. Non-calcified aortic annulus
27. Iliofemoral vessel characteristics that would preclude safe placement of the
introducer sheath such as severe obstructive calcification, or severe tortuosity
(applicable for transfemoral patients only).
Additional Exclusion Criteria (Transcatheter Access Related)
For selection of an appropriate alternative access delivery method, subjects were screened
using the following access specific exclusion criteria:
Transaortic (TAo) Subject Cohort Specific Exclusion Criteria
1. Subject has pre-existing patent RIMA graft that would preclude access.
2. Subject has a hostile chest or other condition that complicates transaortic access.
3. Subject has a porcelain aorta, defined as an extensive circumferential calcification
of the ascending aorta that would complicate TAo access.
Additional exclusion criteria for transaortic access using the FlexNav™ Delivery System:
1. Subject has a distance between the annular plane and the aortic access site <7 cm
(2.8")
2. Subject has a distance between the annular plane and the separate introducer sheath
distal tip <6 cm (2.4")
Subclavian/Axillary Subject Cohort Specific Exclusion Criteria
1. Subject's access vessel (subclavian/axillary) diameter will not allow for introduction
of the applicable 18 Fr or 19 Fr delivery system.
2. Subject's subclavian/axillary arteries have severe calcification and/or tortuosity.
3. Subject's aortic root angulation is:
- Left Subclavian/Left Axillary: >70◦
- Right Subclavian/Right Axillary: >30◦
4. Subject has a history of patent LIMA/RIMA graft that would preclude access
Additional exclusion criteria for subclavian/axillary access using the FlexNav™ Delivery
System:
1. Subject's access vessel (subclavian/axillary) has a distance between the annular plane
and the integrated sheath distal tip <17 cm (6.7")
2. Subject's access vessel requires the delivery system to be advanced through a separate
introducer sheath
Ages Eligible for Study
21 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Recruiting
Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial
The objective of the PORTICO pivotal IDE trial is to evaluate the safety and effectiveness of the St Jude Medical (SJM) Portico Transcatheter Heart Valve and Delivery Systems (Portico) in the treatment of severe symptomatic aortic stenosis via transfemoral and alternative delivery methods in high risk and extreme risk patients.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- device: Portico transcatheter aortic valve
- device: Commercially available transcatheter aortic valve
Eligibility
Inclusion Criteria
1. Subjects must have co-morbidities such that the surgeon and cardiologist
Co-Investigators concur that the predicted risk of operative mortality is ≥15% or a
minimum Society of Thoracic Surgeons (STS) score of 8%. A candidate who does not meet
the STS score criteria of ≥ 8% can be included in the study if a peer review by at
least two surgeons concludes and documents that the patient's predicted risk of
operative mortality is ≥15%. The surgeon's assessment of operative comorbidities not
captured by the STS score must be documented in the study case report form as well as
in the patient medical record.
2. Subject is 21 years of age or older at the time of consent.
3. Subject has senile degenerative aortic valve stenosis with echocardiographically
derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s or
Doppler Velocity Index <0.25 and an initial aortic valve area (AVA) of ≤ 1.0 cm2
(indexed effective orifice area (EOA) ≤ 0.6 cm2/m2). (Qualifying AVA baseline
measurement must be within 60 days prior to informed consent).
4. Subject has symptomatic aortic stenosis as demonstrated by New York Heart Association
(NYHA) Functional Classification of II, III, or IV.
5. The subject has been informed of the nature of the study, agrees to its provisions and
has provided written informed consent as approved by the Institutional Review Board
(IRB) of the respective clinical site.
6. The subject and the treating physician agree that the subject will return for all
required post-procedure follow-up visits.
7. Subject's aortic annulus is 19-27mm diameter as measured by computerized tomography
(CT) conducted within 12 months prior to informed consent. Note: if CT is
contraindicated and/or not possible to be obtained for certain subjects, a 3D echo and
non-contrast CT of chest and abdomen/pelvis may be accepted if approved by the subject
selection committee.
For a subject to be considered an Extreme Risk candidate they must meet # 2, 3, 4, 5,
6, 7 of the above criteria, and
8. The subject, after formal consults by a cardiologist and two cardiovascular surgeons
agree that medical factors preclude operation, based on a conclusion that the
probability of death or serious, irreversible morbidity exceeds the probability of
meaningful improvement. Specifically, the probability of death or serious,
irreversible morbidity should exceed 50%. The surgeons' consult notes shall specify
the medical or anatomic factors leading to that conclusion and include a printout of
the calculation of the STS score to additionally identify the risks in these patients.
Exclusion Criteria
1. Evidence of an acute myocardial infarction (defined as: ST Segment Elevation as
evidenced on 12 Lead ECG) within 30 days prior to index procedure.
2. Aortic valve is a congenital unicuspid or congenital bicuspid valve or is
non-calcified as verified by echocardiography.
3. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant
aortic regurgitation 3-4+).
4. Any percutaneous coronary or peripheral interventional procedure performed within 30
days prior to index procedure.
5. Pre-existing prosthetic heart valve or other implant in any valve position, prosthetic
ring, severe circumferential mitral annular calcification (MAC) which is continuous
with calcium in the left ventricular outflow tract (LVOT), severe (greater than 3+)
mitral insufficiency, or severe mitral stenosis with pulmonary compromise. Subjects
with pre-existing surgical bioprosthetic aortic heart valve should be considered for
the Valve-in-Valve registry.
6. Blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb < 9 g/dL),
thrombocytopenia (platelet count <50,000 cells/mm³).
7. History of bleeding diathesis or coagulopathy.
8. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or
mechanical hemodynamic support.
9. Untreated clinically significant coronary artery disease requiring revascularization.
10. Hemodynamic instability requiring inotropic support or mechanical heart assistance.
11. Need for emergency surgery for any reason.
12. Hypertrophic cardiomyopathy with or without obstruction (HOCM).
13. Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% as
measured by resting echocardiogram.
14. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
15. Active peptic ulcer or upper gastrointestinal (GI) bleeding within 3 months prior to
index procedure.
16. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine
(Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media which cannot be
adequately premedicated.
17. Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA)
or a transient ischemic attack (TIA).
18. Renal insufficiency (creatinine > 3.0 mg/dL) and/or end stage renal disease requiring
chronic dialysis.
19. Life expectancy < 12 months from the time of informed consent due to non-cardiac
co-morbid conditions.
20. Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as
maximal luminal diameter 5cm or greater; marked tortuosity (hyperacute bend), aortic
arch atheroma (especially if thick [> 5 mm], protruding or ulcerated) or narrowing
(especially with calcification and surface irregularities) of the abdominal or
thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta (applicable
for transfemoral patients only).
21. Native aortic annulus size < 19 mm or > 27 mm per the baseline diagnostic imaging.
22. Aortic root angulation > 70° (applicable for transfemoral patients only).
23. Currently participating in an investigational drug or device study.
24. Active bacterial endocarditis within 6 months prior to the index procedure.
25. Bulky calcified aortic valve leaflets in close proximity to coronary ostia.
26. Non-calcified aortic annulus
27. Iliofemoral vessel characteristics that would preclude safe placement of the
introducer sheath such as severe obstructive calcification, or severe tortuosity
(applicable for transfemoral patients only).
Additional Exclusion Criteria (Transcatheter Access Related)
For selection of an appropriate alternative access delivery method, subjects were screened
using the following access specific exclusion criteria:
Transaortic (TAo) Subject Cohort Specific Exclusion Criteria
1. Subject has pre-existing patent RIMA graft that would preclude access.
2. Subject has a hostile chest or other condition that complicates transaortic access.
3. Subject has a porcelain aorta, defined as an extensive circumferential calcification
of the ascending aorta that would complicate TAo access.
Additional exclusion criteria for transaortic access using the FlexNav™ Delivery System:
1. Subject has a distance between the annular plane and the aortic access site <7 cm
(2.8")
2. Subject has a distance between the annular plane and the separate introducer sheath
distal tip <6 cm (2.4")
Subclavian/Axillary Subject Cohort Specific Exclusion Criteria
1. Subject's access vessel (subclavian/axillary) diameter will not allow for introduction
of the applicable 18 Fr or 19 Fr delivery system.
2. Subject's subclavian/axillary arteries have severe calcification and/or tortuosity.
3. Subject's aortic root angulation is:
- Left Subclavian/Left Axillary: >70◦
- Right Subclavian/Right Axillary: >30◦
4. Subject has a history of patent LIMA/RIMA graft that would preclude access
Additional exclusion criteria for subclavian/axillary access using the FlexNav™ Delivery
System:
1. Subject's access vessel (subclavian/axillary) has a distance between the annular plane
and the integrated sheath distal tip <17 cm (6.7")
2. Subject's access vessel requires the delivery system to be advanced through a separate
introducer sheath
Ages Eligible for Study
21 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Recruiting