NCT00610090

Safety Study for the Treatment of Abdominal Aortic Aneurysms

A Phase II, Single-arm, Prospective Study of the Safety of the UniFit Aorto-uni-iliac Endoluminal Stent Graft for the Repair of Abdominal Aortic Aneurysms

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Duke Vascular, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary study objective, at this time, is to follow out to 5 years post implant the safety of already enrolled subjects who were treated with the UniFit Aorto-uni-iliac (AUI) Endoluminal Stent Graft (the "study device") for the repair of abdominal aortic aneurysms (AAAs).

Detailed description

This is a phase II, single-arm, prospective study of the safety of the study device for the repair of AAAs. The investigator will identify eligible patients and explain the study and study device placement procedure to each patient and/or any available family members. Patients who provide written informed consent will be evaluated for study eligibility within the time period identified under Duration of Treatment. Patients who are confirmed to be eligible, based on screening assessment findings, will be enrolled in the study. After hospital discharge, patients will attend study center visits at 30 days, 6 months, and 1, 2, 3, 4, and 5 years post-procedure for follow-up evaluations.

Conditions

• Abdominal Aortic Aneurysms

Interventions

Type	Name	Description
DEVICE	UniFit AAA Stent Graft	Endovascular repair of Abdominal Aortic Aneurysms

Timeline

• Start date: 2007-05-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2008-02-07
• Last updated: 2015-08-25

Locations

19 sites across 1 country: United States