search
Back to results

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

Primary Purpose

Abdominal Aortic Aneurysms

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
UniFit AAA Stent Graft
Sponsored by
Duke Vascular, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysms focused on measuring UNITE, AAA, Abdominal Aortic Aneurysms, Stent, Graft

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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°.

Sites / Locations

  • Loma Linda VA
  • UCLA Medical Center
  • Christiana Hospital
  • Florida Hospital
  • Sacred Heart Hospital
  • Emory University
  • Savannah Vascular Institute
  • Indiana University Hospital
  • Iowa Heart Center
  • University of Massachusetts Medical School
  • William Beaumont Hospital
  • Dartmouth Hitchcock Medical Center
  • Englewood Hospital
  • Albany Medical Center Hospital
  • Dotter Interventional Institute
  • Scott and White Hospital
  • Inova Fairfax Hospital
  • Sentara Healthcare, Vascular and Transplant Specialists
  • Southwest Washington Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment - UniFit AAA Stent Graft

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 24, 2008
Last Updated
August 23, 2015
Sponsor
Duke Vascular, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00610090
Brief Title
Safety Study for the Treatment of Abdominal Aortic Aneurysms
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke Vascular, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysms
Keywords
UNITE, AAA, Abdominal Aortic Aneurysms, Stent, Graft

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment - UniFit AAA Stent Graft
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
UniFit AAA Stent Graft
Other Intervention Name(s)
UniFit, Unite Trial
Intervention Description
Endovascular repair of Abdominal Aortic Aneurysms
Primary Outcome Measure Information:
Title
Primary Objective
Description
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
Time Frame
5 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is 18 years of age or older Patient has a AAA that meets one of the following criteria: Aneurysm diameter of greater than 4.5 cm, or less than 4.5 cm with rapid expansion 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°.
Facility Information:
Facility Name
Loma Linda VA
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Sacred Heart Hospital
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Savannah Vascular Institute
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
Facility Name
Indiana University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46206
Country
United States
Facility Name
Iowa Heart Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Englewood Hospital
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
Albany Medical Center Hospital
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Dotter Interventional Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Inova Fairfax Hospital
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Sentara Healthcare, Vascular and Transplant Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Southwest Washington Medical Center
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety Study for the Treatment of Abdominal Aortic Aneurysms

We'll reach out to this number within 24 hrs