Status:
TERMINATED
Safety Study for the Treatment of Abdominal Aortic Aneurysms
Lead Sponsor:
Duke Vascular, Inc.
Conditions:
Abdominal Aortic Aneurysms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 Gra...
Detailed 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 pla...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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°.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00610090
Start Date
May 1 2007
End Date
December 1 2015
Last Update
August 25 2015
Active Locations (19)
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1
Loma Linda VA
Loma Linda, California, United States, 92354
2
UCLA Medical Center
Torrance, California, United States, 90502
3
Christiana Hospital
Newark, Delaware, United States, 19713
4
Florida Hospital
Orlando, Florida, United States, 32803