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).
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
71
Endovascular repair of Abdominal Aortic Aneurysms
Loma Linda VA
Loma Linda, California, United States
UCLA Medical Center
Torrance, California, United States
Primary Objective
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
Time frame: 5 year
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Newark, Delaware, United States
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University of Massachusetts Medical School
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...and 9 more locations