A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms (AAA IDE)
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.
Abdominal Aortic Aneurysm
Device: TriVascular Stent-Graft System
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms|
- Number of Participants Without a Device Related Adverse Events Within 1 Month of the Study Procedure. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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.
- Number of Participants Who Achieve Technical Success of the Stent Graft System. [ Time Frame: Post procedure ] [ Designated as safety issue: Yes ]Technical success was defined as successful introduction of the delivery catheter into the arterial system at the time of the study procedure and successful delivery/deployment of the stent graft system to the intended location with the absence of device related surgical conversion and intra-operative mortality. Device related surgical conversion is defined as the inability to deliver or deploy the stent graft system, then subsequently surgically treating the patient.
|Study Start Date:||February 2003|
|Study Completion Date:||March 2010|
|Primary Completion Date:||November 2004 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
This arm is for patient that receive the TriVascular Stent-Graft System.
Device: TriVascular Stent-Graft System
TriVascular Stent-Graft System
|United States, California|
|Harbor UCLA Medical Center|
|Torrance, California, United States, 90509|
|United States, District of Columbia|
|Georgetown University Pasquerilla Healthcare|
|Washington, District of Columbia, United States, 20007|
|United States, Florida|
|University of Florida - Shands Hospital|
|Gainesville, Florida, United States, 32610|
|Miami Cardiac & Vascular Institute Baptist Hospital|
|Miami, Florida, United States, 33176|
|United States, New York|
|Albany Medical College|
|Albany, New York, United States, 12208|
|United States, Pennsylvania|
|University of Pennsylvania Medical Center|
|Philadelphia, Pennsylvania, United States, 19104|
|University of Pittsburgh Shadyside Hospital|
|Pittsburgh, Pennsylvania, United States, 15232|
|Study Director:||Pamela Grady, PhD||Boston Scientific Corporation|