Safety Study for the Treatment of Abdominal Aortic Aneurysms

Abdominal Aortic Aneurysms Clinical Trial

— UNITE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00610090
• Other study ID #: LMV-AUI-P2-001
• Status: Terminated
• Phase: Phase 2
• First received: January 24, 2008
• Last updated: August 23, 2015
• Start date: May 2007
• Est. completion date: December 2015

Study information

• Verified date: May 2015
• Source: Duke Vascular, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 71
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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°.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysms
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• UniFit AAA Stent Graft
Endovascular repair of Abdominal Aortic Aneurysms

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Duke Vascular, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes