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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Duke Vascular, Inc.
Information provided by (Responsible Party):
LeMaitre Vascular
ClinicalTrials.gov Identifier:
NCT00610090
First received: January 24, 2008
Last updated: March 14, 2012
Last verified: March 2012
  Purpose

The primary study objective is to determine the safety and efficacy of the UniFit Aorto-uni-iliac (AUI) Endoluminal Stent Graft (the "study device") for the repair of abdominal aortic aneurysms (AAAs) in patients who are not candidates for repair with commercially available bifurcated endovascular prostheses and considered high risk for conventional surgical repair.


Condition Intervention Phase
Abdominal Aortic Aneurysms
Device: UniFit AAA Stent Graft
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Single-arm, Prospective Study of the Safety and Efficacy of the UniFit Aorto-uni-iliac Endoluminal Stent Graft for the Repair of Abdominal Aortic Aneurysms

Resource links provided by NLM:


Further study details as provided by LeMaitre Vascular:

Primary Outcome Measures:
  • The MAE rate through Day 30 post-procedure. Effectiveness, as measured by the following: Absence of device-related endoleak Absence of device-related aneurysm enlargement Absence of major device efficacy adverse events [ Time Frame: 30 Days and 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Death due to any cause prior to Day 30 post-procedure. Amount of blood loss during study procedure. Duration of time in ICU. Proportion of patients requiring time in ICU. Duration of hospital stay. [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: May 2007
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: UniFit AAA Stent Graft
    Endovascular repair of Abdominal Aortic Aneurysms
    Other Names:
    • UniFit
    • Unite Trial
Detailed Description:

This is a phase II, single-arm, prospective study of the safety and efficacy 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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°.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610090

Locations
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
LeMaitre Vascular
Duke Vascular, Inc.
Investigators
Principal Investigator: Rodney A White, M.D. University of California, Los Angeles
Principal Investigator: Karthik Kasirajan, M.D. Emory University
  More Information

No publications provided

Responsible Party: LeMaitre Vascular
ClinicalTrials.gov Identifier: NCT00610090     History of Changes
Other Study ID Numbers: LMV-AUI-P2-001
Study First Received: January 24, 2008
Last Updated: March 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by LeMaitre Vascular:
UNITE
AAA
Abdominal Aortic Aneurysms
Stent
Graft

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

ClinicalTrials.gov processed this record on October 01, 2014