Ronald L. Dalman MD
Endovascular repair of abdominal aortic aneurysm with angled aorta, angled aneurysmal body or both.
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The purpose of the study is to evaluate the safety and effectiveness of the Lombard Medical endovascular Aorfix AAA bifurcated stent graft range in aneurysms with anatomy including angled aorta, angled aneurysmal body or both, where the patients have suitable anatomy.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Procedure: Open surgical repair of abdominal aortic aneurysm
- Procedure: Endovascular repair of abdominal aortic aneurysm
Phase:
Phase 2/Phase 3Eligibility
Ages Eligible for Study:
21 years to 85 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
1. Diagnosed abdominal aortic aneurysm with aortic neck angles up to 90?, > 4.5 cm in diameter, OR 4.0 cm or larger in diameter if symptomatic (i.e. pain, embolisation), OR documented AAA growth of more than 5 mm within the previous 6 months, and/or including extension into common iliac artery(ies), and/or
2. Iliac aneurysm greater than, or equal to 3.5 cm in maximum diameter.
Key Exclusion Criteria:
General
1. Less than 21 years of age,
2. Life expectancy less than 2 years,
3. Pregnant,
4. Religious, cultural or other objection to the receipt of blood, or blood products,
5. Unwillingness to comply with follow-up schedule,
6. Unwillingness or inability to provide informed consent to both trial and procedure.
Medical
1. Patients not expected to live more than 2 years from enrolment and in no case >85 years.
2. Patient has a ruptured aneurysm.
3. Aneurysm extends above renal arteries.
4. Aorta between superior mesenteric artery (SMA) and aneurysm has significant loose thrombus associated with it.
5. Patient with an acute or chronic aortic dissection or mycotic aneurysm.
6. Patient has current non-localized infection (may be recruited following remission of the infection).
7. Patient is allergic to device materials,
8. Patient is allergic to or intolerant of use of contrast media and cannot be exposed to suitable remedial treatment such as steroids and/or benadryl.
9. Patient is clinically and morbidly obese such that imaging would be severely adversely affected.
10. Patient has renal failure (serum creatinine > 2.5mg/dL).
11. Patient has an uncorrectable bleeding abnormality.
12. Patient has unstable angina.
13. Patient is receiving dialysis.
14. Inflammatory aneurysm.
15. MI in last 6 months.
16. End stage COPD.
17. Patient has connective tissue disease (e.g. Marfan syndrome, Ehlers-Danlos syndrome).
18. Significant (>80%) renal artery stenosis which cannot be readily treated.
Endovascular arm exclusion criteria:
1. Patient has co-morbidities that deny vascular access, or small access vessels.
2. Patient has highly calcified and/or tortuous proximal neck or distal landing zones or iliac arteries.
3. Patient has insufficient length of proximal aneurysm neck (< 15mm from lowest renal artery) or SMA to aneurysm distance is less than 20mm,
4. Patient has insufficient length of distal landing zone (< 15mm).
5. Proximal neck is outside of device range (reference sizing tables, 5).
6. The iliac artery diameter (landing zone) is larger than 19 mm in diameter (reference sizing tables, section 5).
7. Indispensable Inferior Mesenteric Artery (IMA),
8. Inability to maintain at least one patent hypogastric artery,
9. Excessive calcification, such as a ring, or near ring of calcified plaque around an iliac artery.
Open arm exclusion criteria:
1. Excessive calcification or occlusive disease which would prevent open repair in the opinion of the principle site investigator,
2. Any portion of the aneurysm is supra-renal,
3. Aneurysm involves visceral arteries,
4. Otherwise eligible for the endovascular arm.
Additional Study Details
Official Title:
Prospective aneurYsm Trial: High AnGle AORfix? bifurcAted Stent graftAnticipated start date:
10/18/2007Lead Sponsor:
Lombard MedicalInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- The twelve month, all cause mortality rate in the Aorfix? group compared to all cause mortality rate in the control group. [Time Frame: 1 year]
Secondary Outcomes:
- Aneurysms in the endovascular group shall demonstrate significant shrinkage in volume (i.e. > 5%) in at least 60% of cases.
- Grafts shall remain patent in at least 80% of cases.
- The rates of early serious adverse events between 0 and 30 days post-operative in the Aorfix? groups compared to the early serious adverse event rates between 0 and 30 days post-operative in the control group. [Time Frame: 30 days]
- All cause mortality of the endovascular group within 12 months post-operative shall be non-inferior to all cause mortality in the control group.
Total Number to be Enrolled:
275Total Number to be Enrolled at Stanford:
20More Information
Secondary ID(s):
- IRB eprotocol number: 9232
- SPO number: 39827
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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