Safety Study for the Treatment of Abdominal Aortic Aneurysms

Stopped early · Phase 2

Conditions studied: Abdominal Aortic Aneurysms

In brief

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).

Key facts

Study ID

NCT00610090

Run by

Duke Vascular, Inc.

People needed

71

Starts

2007-05-01

Expected to finish

2015-12-01

Last updated by the study team

2015-08-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Patient is a candidate for a bifurcated endovascular graft.
• Patient has an aortic trunk with an angle greater than 90°.

Where it is running

• Loma Linda VA — Loma Linda, California, United States
• UCLA Medical Center — Torrance, California, United States
• Christiana Hospital — Newark, Delaware, United States
• Florida Hospital — Orlando, Florida, United States
• Sacred Heart Hospital — Pensacola, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Savannah Vascular Institute — Savannah, Georgia, United States
• Indiana University Hospital — Indianapolis, Indiana, United States
• Iowa Heart Center — Des Moines, Iowa, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Englewood Hospital — Englewood, New Jersey, United States
• Albany Medical Center Hospital — Albany, New York, United States
• Dotter Interventional Institute — Portland, Oregon, United States
• Scott and White Hospital — Temple, Texas, United States
• Inova Fairfax Hospital — Fairfax, Virginia, United States
• Sentara Healthcare, Vascular and Transplant Specialists — Norfolk, Virginia, United States
• Southwest Washington Medical Center — Vancouver, Washington, United States

Full record on ClinicalTrials.gov

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