Status:
COMPLETED
A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Abdominal Aortic Aneurysm
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study was a prospective observational study examined the safety of the TriVascular AAA Stent-Graft System in the elective treatment of patients with abdominal aortic aneurysms. Specifically, the ...
Eligibility Criteria
Inclusion
- Male or infertile female
- Have signed an informed consent form.
- Are considered an appropriate candidate for open surgical repair of an abdominal aortic aneurysm.
- at least one of the following: Abdominal aortic aneurysm \>= 4.5 cm in diameter; aneurysm has increased in size by 0.5cm in last 6 months; maximum diameter of aneurysm exceeds 1.5 times the transverse dimension of an adjacent normal aortic segment; saccular aneurysm larger than 3 cm.
- Have patent iliac or femoral arteries that allow endovascular access to the aneurysmal site with a 17F Delivery Catheter.
Exclusion
- A dissecting, acutely ruptured, or leaking aneurysm, or an acute vascular injury due to trauma.
- A need for emergent surgery.
- contraindication to undergoing angiography.
- A Thoracic aortic aneurysm that requires treatment.
- Presence of thrombus or atheroma in proximal aortic neck covering \> 50% of the endoluminal surface.
- Presence of diffuse atherosclerotic disease in either common iliac artery that reduces the iliac artery diameter to \<7mm.
- Congenital abnormalities in which the placement of the stent-graft will cause occlusion of major arterial flow. Such abnormalities should be evaluated(e.g. angiography or CT) prior to treatment.
- Unstable angina
- Morbid obesity or other clinical conditions that severely inhibit x-ray visualization of the aorta.
- Connective tissue disease (e.g., Marfan's or Ehlers-Danlos syndrome.)
- Hypercoagulable state.
- Contraindication for anticoagulation.
- Acute renal failure.
- Active systemic infection.
- less than 18 years of age.
- Life expectancy less than 1 year.
- Current, or anticipated participation within 1 year, in another research study involving an investigational device or new drug (with the exception of participation in the Lifeline Registry of Endovascular Therapy).
- Other medical, social, or psychological issues that in the opinion of the investigator preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00646048
Start Date
February 1 2003
End Date
March 1 2010
Last Update
January 28 2011
Active Locations (7)
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1
Harbor UCLA Medical Center
Torrance, California, United States, 90509
2
Georgetown University Pasquerilla Healthcare
Washington D.C., District of Columbia, United States, 20007
3
University of Florida - Shands Hospital
Gainesville, Florida, United States, 32610
4
Miami Cardiac & Vascular Institute Baptist Hospital
Miami, Florida, United States, 33176