Brief Title
Safety Study for the Treatment of Abdominal Aortic Aneurysms
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 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
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
Primary Objective
Condition
Abdominal Aortic Aneurysms
Intervention
UniFit AAA Stent Graft
Study Arms / Comparison Groups
Treatment - UniFit AAA Stent Graft
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
71
Start Date
May 2007
Completion Date
December 2015
Primary Completion Date
December 2015
Eligibility Criteria
Inclusion Criteria:
- Patient is 18 years of age or older
- Patient has a AAA that meets one of the following criteria:
1. Aneurysm diameter of greater than 4.5 cm, or less than 4.5 cm with rapid
expansion
2. 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 Criteria:
- 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°.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00610090
Organization ID
LMV-AUI-P2-001
Responsible Party
Sponsor
Study Sponsor
Duke Vascular, Inc.
Study Sponsor
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Verification Date
May 2015