A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Abdominal Aortic Aneurysm
- Sponsor
- Boston Scientific Corporation
- Enrollment
- 43
- Locations
- 7
- Primary Endpoint
- Number of Participants Without a Device Related Adverse Events Within 1 Month of the Study Procedure.
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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 study will evaluate the safety of the TriVascualr AAA Stent-Graft System, evaluate the ability to deliver the Tri-Vascular AAA Stent-Graft System to the desired location within the aorta, and evaluate the ability of the TriVascular AAA Stent-Graft to exclude the abdominal aortic aneurysm.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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.)
Outcomes
Primary Outcomes
Number of Participants Without a Device Related Adverse Events Within 1 Month of the Study Procedure.
Time Frame: 1 month
Device related adverse events included, but were not limited to: Stent Graft Migration, Vessel dissection or perforation, stent graft occlusion, branch vessel occlusion, aneurysm rupture.
Number of Participants Without a Type I, III, and/or IV Endoleak at 1 Month Follow-up Identified by Computed Tomography (CT).
Time Frame: 1 month
A Type I endoleak is a persistent perigraft channel of blood flow that develops due to inadequate or ineffective seal at the graft ends (attachment zones). A Type III endoleak occurs in the midgraft region due to leakage through a defect in the graft fabric or between the segments of a multisegmental graft. A Type IV endoleak is seen on completion of angiography or subsequent contrast studies as any blush of contrast that is presumed to emanate from blood diffusion across the porous graft fabric or through small holes in the graft cause by sutures or stent struts.
Secondary Outcomes
- Number of Participants Who Achieve Technical Success of the Stent Graft System.(Post procedure)