Clinical trial NCT00610090: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Abdominal Aortic Aneurysms
Keywords: UNITE
AAA
Abdominal Aortic Aneurysms
Stent
Graft
Lead sponsor: Duke Vascular, Inc.
Sponsor class: INDUSTRY
First posted: 2008-02-07
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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°.

Primary outcomes:
measure: Primary Objective
timeFrame: 5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda VA
state: California
city: Torrance
country: United States
facility: UCLA Medical Center
state: California
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Pensacola
country: United States
facility: Sacred Heart Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Savannah
country: United States
facility: Savannah Vascular Institute
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Englewood
country: United States
facility: Englewood Hospital
state: New Jersey
city: Albany
country: United States
facility: Albany Medical Center Hospital
state: New York
city: Portland
country: United States
facility: Dotter Interventional Institute
state: Oregon
city: Temple
country: United States
facility: Scott and White Hospital
state: Texas
city: Fairfax
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Norfolk
country: United States
facility: Sentara Healthcare, Vascular and Transplant Specialists
state: Virginia
city: Vancouver
country: United States
facility: Southwest Washington Medical Center
state: Washington
Study officials:
References: