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Safety Study for the Treatment of Abdominal Aortic Aneurysms — UNITE  

Abdominal Aortic Aneurysms Clinical Trial

Official title:
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

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00610090
Study type Interventional
Source Duke Vascular, Inc.
Contact
Status Terminated
Phase Phase 2
Start date May 2007
Completion date December 2015
View Details
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