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

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

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).

Study Overview

• Status: Terminated
• Conditions: Abdominal Aortic Aneurysms
• Intervention / Treatment: Device: UniFit AAA Stent Graft

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
• Enrollment (Actual): 71
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Duke Vascular, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: January 24, 2008
• First Submitted That Met QC Criteria: January 24, 2008
• First Posted (Estimate): February 7, 2008

Study Record Updates

• Last Update Posted (Estimate): August 25, 2015
• Last Update Submitted That Met QC Criteria: August 23, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Stent; AAA; Graft; Abdominal Aortic Aneurysms; UNITE
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: LMV-AUI-P2-001