Clinical Trial: Safety Study for the Treatment of Abdominal Aortic Aneurysms
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
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
Brief 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 Summary:
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.
Sponsor: Duke Vascular, Inc.
Current Primary Outcome: Primary Objective [ Time Frame: 5 year ]
The primary objective, at this time, is to ensure the safety of already enrolled and treated subjects. The data resulting from this study will not be used for any regulatory or commercialization purpose.
The current sponsor, Duke Vascular, Inc. is requesting closure of this IDE
Original Primary Outcome: The MAE rate through Day 30 post-procedure. Effectiveness, as measured by the following: Absence of device-related endoleak Absence of device-related aneurysm enlargement Absence of major device efficacy adverse events [ Time Frame: 30 Days and 1 year ]
Current Secondary Outcome:
Original Secondary Outcome: Death due to any cause prior to Day 30 post-procedure. Amount of blood loss during study procedure. Duration of time in ICU. Proportion of patients requiring time in ICU. Duration of hospital stay. [ Time Frame: 30 days and 1 year ]
Information By: Duke Vascular, Inc.
Dates:
Date Received: January 24, 2008
Date Started: May 2007
Date Completion: December 2015
Last Updated: August 23, 2015
Last Verified: May 2015
