Clinical Trial: A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms

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.

Detailed Summary:
Sponsor: Boston Scientific Corporation

Current Primary Outcome:

  • 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.


Original Primary Outcome:

  • Absence of device related adverse events within 1 month of the endovascular procedure [ Time Frame: 1 month, 6 months, 1 year, annually through 5 year follow up ]
  • Absence of Types I, II, and IV endoleaks at 1 month follow-up [ Time Frame: 1 month, 6 months, 1 year, annually through 5 year follow up ]


Current Secondary Outcome: Number of Participants Who Achieve Technical Success of the Stent Graft System. [ Time Frame: Post procedure ]

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.


Original Secondary Outcome:

  • Success in introduction of the delivery catheter into the arterial system [ Time Frame: Post procedure ]
  • Deployment of the stent-graft in the desired location in the absence of device-related surgical conversion and intra-operative mortality. [ Time Frame: Post procedure ]


Information By: Boston Scientific Corporation

Dates:
Date Received: March 26, 2008
Date Started: February 2003
Date Completion:
Last Updated: January 26, 2011
Last Verified: January 2011