Safety Study for the Treatment of Abdominal Aortic Aneurysms (UNITE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00610090
Recruitment Status : Terminated
First Posted : February 7, 2008
Last Update Posted : August 25, 2015
Information provided by (Responsible Party):
Duke Vascular, Inc.

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).

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysms Device: UniFit AAA Stent Graft Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2007
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment - UniFit AAA Stent Graft Device: UniFit AAA Stent Graft
Endovascular repair of Abdominal Aortic Aneurysms
Other Names:
  • UniFit
  • Unite Trial

Primary Outcome Measures :
  1. Primary Objective [ Time Frame: 5 year ]

    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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°.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00610090

United States, California
Loma Linda VA
Loma Linda, California, United States, 92354
UCLA Medical Center
Torrance, California, United States, 90502
United States, Delaware
Christiana Hospital
Newark, Delaware, United States, 19713
United States, Florida
Florida Hospital
Orlando, Florida, United States, 32803
Sacred Heart Hospital
Pensacola, Florida, United States, 32504
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Savannah Vascular Institute
Savannah, Georgia, United States, 31404
United States, Indiana
Indiana University Hospital
Indianapolis, Indiana, United States, 46206
United States, Iowa
Iowa Heart Center
Des Moines, Iowa, United States, 50266
United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Englewood Hospital
Englewood, New Jersey, United States, 07631
United States, New York
Albany Medical Center Hospital
Albany, New York, United States, 12208
United States, Oregon
Dotter Interventional Institute
Portland, Oregon, United States, 97239
United States, Texas
Scott and White Hospital
Temple, Texas, United States, 76508
United States, Virginia
Inova Fairfax Hospital
Fairfax, Virginia, United States, 22042
Sentara Healthcare, Vascular and Transplant Specialists
Norfolk, Virginia, United States, 23507
United States, Washington
Southwest Washington Medical Center
Vancouver, Washington, United States, 98664
Sponsors and Collaborators
Duke Vascular, Inc.

Responsible Party: Duke Vascular, Inc. Identifier: NCT00610090     History of Changes
Other Study ID Numbers: LMV-AUI-P2-001
First Posted: February 7, 2008    Key Record Dates
Last Update Posted: August 25, 2015
Last Verified: May 2015

Keywords provided by Duke Vascular, Inc.:
Abdominal Aortic Aneurysms

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases