Safety Study for the Treatment of Abdominal Aortic Aneurysms
UNITE
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
1 other identifier
interventional
71
1 country
19
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2007
Longer than P75 for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 24, 2008
CompletedFirst Posted
Study publicly available on registry
February 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedAugust 25, 2015
May 1, 2015
8.6 years
January 24, 2008
August 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
5 year
Study Arms (1)
Treatment - UniFit AAA Stent Graft
EXPERIMENTALInterventions
Endovascular repair of Abdominal Aortic Aneurysms
Eligibility Criteria
You may qualify if:
- Patient is 18 years of age or older
- Patient has a AAA that meets one of the following criteria:
- Aneurysm diameter of greater than 4.5 cm, or less than 4.5 cm with rapid expansion
- The aneurysm has a saccular configuration where potential for rupture is increased or has exhibited dissection with potential for rupture at, or compromised flow to, vital structures
- The vessels immediately proximal and distal to the lesion are capable of accommodating the study device
- The access artery diameter and profile of the artery are capable of study device delivery.
- Patient has proximal and distal neck lengths of greater than or equal to 1.0 cm
- Patient is willing and able to comply with the follow-up regime.
- Patient has provided written informed consent.
You may not qualify if:
- Patient has an aortic diameter greater than 36 mm.
- Patients with ASA score less than 3 and deemed low risk by the Investigator for open surgical repair.
- Patient has an indispensable inferior mesenteric artery.
- Patient has a distal landing zone of \< 2 cm in length or \> 16 mm in diameter
- Patient has iliac arteries whose tortuosity prevents passage of the introducer catheter.
- If female, patient is pregnant
- Patient has a life expectancy less than two years.
- Patient has an allergy to any of the study device materials
- Patient has coagulopathy or bleeding disorders
- Patient for whom contrast medium or anticoagulation drugs are contraindicated
- Patient has an uncontained rupture of the aneurysm.
- Patient has an active systemic or localized groin infection
- Patient has a connective tissue disease.
- Patient has a GFR \< 30 ml/min/1.73m2
- Patient has a circumferential mural thrombus at the implantation site.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Loma Linda VA
Loma Linda, California, 92354, United States
UCLA Medical Center
Torrance, California, 90502, United States
Christiana Hospital
Newark, Delaware, 19713, United States
Florida Hospital
Orlando, Florida, 32803, United States
Sacred Heart Hospital
Pensacola, Florida, 32504, United States
Emory University
Atlanta, Georgia, 30322, United States
Savannah Vascular Institute
Savannah, Georgia, 31404, United States
Indiana University Hospital
Indianapolis, Indiana, 46206, United States
Iowa Heart Center
Des Moines, Iowa, 50266, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Englewood Hospital
Englewood, New Jersey, 07631, United States
Albany Medical Center Hospital
Albany, New York, 12208, United States
Dotter Interventional Institute
Portland, Oregon, 97239, United States
Scott and White Hospital
Temple, Texas, 76508, United States
Inova Fairfax Hospital
Fairfax, Virginia, 22042, United States
Sentara Healthcare, Vascular and Transplant Specialists
Norfolk, Virginia, 23507, United States
Southwest Washington Medical Center
Vancouver, Washington, 98664, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2008
First Posted
February 7, 2008
Study Start
May 1, 2007
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
August 25, 2015
Record last verified: 2015-05