Ronald L. Dalman MD
Safety and effectiveness study of Endurant Stent Graft System as endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms.
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The purpose of the study is to demonstrate that the Endurant Stent Graft System is safe and effective for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Device: Endovascular repair of Abdominal Aortic Aneurysm
Phase:
N/AEligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
Inclusion Criteria for the Bifurcated Study Arm:
1. Subject is >= 18 years old.
2. Subject (or Subject's legal representative) understands and voluntarily has signed and dated an Informed Consent document approved by the Sponsor and by the Institutional Review Board.
3. Subject is able and willing to comply with the protocol and undergo follow-up requirements.
4. Subject is a suitable candidate for elective surgical repair of AAA by as evaluated by American Society
of Anesthesiologists (ASA) Physical Status Classification System I, II, or III.
5. Subject has an abdominal aortic or aortoiliac aneurysm characterized by one or more of the following:
a. Aneurysm is > 5cm in diameter (diameter measured is perpendicular to the line of flow).
b. Aneurysm is 4 - 5 cm in diameter and has increased in size >= 0.5 cm within the last 6 months.
6. Subject meets all the following anatomical criteria* as demonstrated on contrast-enhanced CT or MRA imaging:
a. Suprarenal angle <= 45 degrees (angle between the proximal neck and the suprarenal aorta).
b. Infrarenal angulation <= 60 degrees (angle between the proximal neck and the aneurysm).
c. Infrarenal aneurismal neck length with at least 10 mm of non-aneurismal aorta, immediately inferior to the most inferior major renal artery.
7. Subject has vascular dimensions, e.g., aortic and iliac diameters, lengths from renal arteries to iliac bifurcation and hypogastric arteries, in the range of sizes available for the Endurant Stent Graft (measured intima to intima) and within the sizing recommendations.
8. Subject has a proximal aortic neck diameter >= 19 mm and <= 32 mm.
9. The distal fixation center of the iliac arteries must have a diameter >= 8 mm and <= 25 mm.
10. Subject has documented imaging evidence of at least 1 patent iliac and 1 femoral artery, or can tolerate a vascular conduit that allows introduction of the device.
11. Subject has distal non-aneurysmal iliac (cylindrical) fixation length >= 15 mm bilaterally.
Inclusion Criteria for the AUI study arm:
1. Subject is >= 18 years old.
2. Subject (or Subject's legal representative) understands and voluntarily has signed and dated an Informed Consent document approved by the Sponsor and by the Institutional Review Board.
3. Subject is able and willing to comply with the protocol and undergo follow-up requirements.
4. Subject is a suitable candidate for elective surgical repair of AAA by as evaluated by American Society
of Anesthesiologists (ASA) Physical Status Classification System I, II, III, or IV.
5. Subject has an abdominal aortic or aortoiliac aneurysm characterized by one or more of the following:
a. Aneurysm is > 5cm in diameter (diameter measured is perpendicular to the line of flow).
b. Aneurysm is 4 - 5 cm in diameter and has increased in size >= 0.5 cm within the last 6 months.
c. Aneurysm diameter is 1.5 times that of the non-aneurysmal abdominal aorta.
6. Subject meets all the following anatomical criteria as demonstrated on contrastenhanced CT or MRA imaging:
d. Suprarenal angle <= 45 degrees (angle between the proximal neck and the suprarenal aorta).
e. Infrarenal angulation <= 60 degrees (angle between the proximal neck and the aneurysm).
f. Infrarenal aneurismal neck length with at least 10 mm of non-aneurismal aorta, immediately inferior to the most inferior major renal artery.
7. Subject has vascular dimensions, e.g., aortic and iliac diameters, lengths from renal arteries to iliac bifurcation and hypogastric arteries, in the range of sizes available for the Endurant Stent Graft (measured intima to intima) and within the sizing recommendations.
8. Subject has a proximal aortic neck diameter >= mm and <= 32 mm.
9. The distal fixation center of the iliac artery must have a diameter >= 8 mm and <= 25 mm.
10. Subject has documented imaging evidence of at least 1 patent iliac and 1 femoral artery, or can tolerate a vascular conduit that allows introduction of the device.
11. Subject has distal non-aneurysmal iliac (cylindrical) fixation length ?? 15 mm unilaterally.
12. Subject's native vessel anatomy is more suited for the introduction and/ or deployment of an Endurant Uni-Iliac Stent Graft System due to:
a. Severe unilateral access vessel occlusion/ stenosis that would compromise the introduction of the
Endurant Contra-lateral Iliac limb Delivery System, or
b. Unilateral Iliac vessel ectasia that would compromise distal landing zone fixation and seal, or
c. Unilateral significant (> 25% of vessel circumference of iliac artery, and/or > 50% of the length of the iliac artery) mural thrombus at the distal attachment landing zone that would compromise fixation and seal, or
d. Severe unilateral access vessel angulation, or
e. Severe unilateral access vessel tortuosity, or
f. Severe unilateral access vessel calcification, or
g. Severe unilateral landing zone vessel calcification, or
h. Distal aneurysmal neck (immediately beneath the AAA) unable to reasonably accommodate a Bifurcated Endurant Stent Graft
Key Exclusion Criteria:
Exclusion Criteria for the Bifurcated Study Arm:
1. Subject has a life expectancy <= 1 year.
2. Subject is participating in another investigational drug or device study and has not completed the follow-up required for that study at least 1 month prior to signing the consent form in this study.
3. Subject is a female of childbearing potential in whom pregnancy cannot be excluded. A pregnancy test with negative results is required at the time of screening.
4. Subject has an aneurysm that is:
a. Suprarenal.
b. Isolated ilio-femoral.
c. Mycotic.
d. Inflammatory.
e. Pseudoaneurysm.
5. Subject has an untreated thoracic aneurysm > 4.5 cm in diameter.
6. Subject requires emergent aneurysm treatment, e.g., trauma or rupture.
7. Subject has an aneurysm that involves the part of the aorta at the ostia of the renal arteries.
8. Subject has a history of bleeding diathesis or coagulopathy.
9. Subject has had or plans to have an unrelated major surgical or interventional procedure within 1 month
before or after implantation of the Endurant Stent Graft.
10. Subject has had a MI or cerebral vascular accident (CVA) within 3 months prior to implantation of the Endurant Stent Graft.
11. Subject has a reversed conical neck defined as a > 4 mm distal increase over a 10 mm length.
12. Subject has a known allergy or intolerance to the device components.
13. Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment.
14. Subject has significant (> 25% of vessel circumference of aortic neck and iliac artery, and/or > 50% of the length of the iliac artery) aortic mural thrombus at either the proximal or distal attachment centers that would compromise fixation and seal of the device.
15. Subject has ectatic iliac arteries requiring bilateral exclusion of hypogastric blood flow.
16. Subject whose arterial access site is not anticipated to accommodate the diameter of the Endurant Stent Graft Delivery System (14F-20F) due to size or tortuosity.
17. Subject is morbidly obese (body mass index >= 40 kg/m2) or has other documented clinical conditions that severely inhibit radiographic visualization of the aorta.
18. Subject has active infection at the time of the index procedure documented by pain, fever, drainage, positive culture and/or leukocytosis (WBC > 11,000 mm3) that is treated with antimicrobial agents (nonprophylactic).
19. Subject has congenital degenerative collagen disease, e.g., Marfan's Syndrome.
20. Subject has a creatinine > 2.00 mg/dl (or >182 umol/L).
21. Subject is on dialysis.
Exclusion Criteria for the AUI study arm:
1. Subject has a life expectancy <= 1 year.
2. Subject is participating in another investigational drug or device study and has not completed the follow-up required for that study at least 1 month prior to signing the consent form in this study.
3. Subject is a female of childbearing potential in whom pregnancy cannot be excluded. A pregnancy test with negative results is required at the time of screening.
4. Subject has an aneurysm that is:
a. Suprarenal.
b. Isolated ilio-femoral.
c. Mycotic.
d. Inflammatory.
e. Pseudoaneurysm.
5. Subject has an untreated thoracic aneurysm > 4.5 cm in diameter.
6. Subject requires emergent aneurysm treatment, e.g., trauma or rupture.
7. Subject has an aneurysm that involves the part of the aorta at the ostia of the renal arteries.
8. Subject has a history of bleeding diathesis or coagulopathy.
9. Subject has had or plans to have an unrelated major surgical or interventional procedure within 1 month before or after implantation of the Endurant Stent Graft.
10. Subject has had a MI or cerebral vascular accident (CVA) within 3 months prior to implantation of the Endurant Stent Graft.
11. Subject has a reversed conical neck defined as a > 4 mm distal increase over a 10 mm length.
12. Subject has a known allergy or intolerance to the device components.
13. Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment.
14. Subject has significant (> 25% of vessel circumference of aortic neck and iliac artery, and/or > 50% of the length of the iliac artery) aortic mural thrombus at either the proximal or distal attachment centers bilaterally that would compromise fixation and seal of the device.
15. Subject has iliac anatomy requiring bilateral exclusion of hypogastric blood flow.
16. Subject whose arterial access site is not anticipated to accommodate the diameter of the Endurant Stent Graft Delivery System (14F-20F) due to size or tortuosity.
17. Subject is morbidly obese (body mass index >= 40 kg/m2) or has other documented clinical conditions that severely inhibit radiographic visualization of the aorta.
18. Subject has active infection at the time of the index procedure documented by pain, fever, drainage,
positive culture and/or leukocytosis (WBC > 11,000 mm3) that is treated with antimicrobial agents
(nonprophylactic).
19. Subject has congenital degenerative collagen disease, e.g., Marfan's Syndrome.
20. Subject has a creatinine > 2.00 mg/dl (or >182 umol/L).
21. Subject is on dialysis
22. Subject#s native vessel anatomy able to accommodate any Bifurcated Stent Graft.
Additional Study Details
Official Title:
Endurant Stent Graft System US Clinical StudyAnticipated start date:
6/1/2008Lead Sponsor:
Medtronic Vascular, Inc.Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- Treatment Success through 12 months
Secondary Outcomes:
- Safety and efficacy through 12 months
Total Number to be Enrolled:
194Total Number to be Enrolled at Stanford:
5More Information
Secondary ID(s):
- IRB Protocol Number: 15279
- SPO Number: 43583
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
8/19/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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