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Zenith(R) Low Profile AAA Endovascular Graft Clinical Study

Primary Purpose

Abdominal Aortic Aneurysms, Iliac Aneurysms, Aorto-iliac Aneurysms

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Zenith(R) Low Profile AAA Endovascular Graft
Sponsored by
Cook Group Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysms focused on measuring Low Profile, Abdominal Aortic Aneurysms, Endovascular

Eligibility Criteria

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

Inclusion Criteria:

  • Abdominal aortic, aortoiliac, and iliac aneurysms of appropriate size
  • Vessels suitable for endovascular access and aneurysm repair

Exclusion Criteria:

  • Less than 18 years of age
  • Inability or refusal to give informed consent
  • Disease considerations that would compromise patient safety or study outcomes
  • Unsuitable arterial anatomy

Sites / Locations

  • University of California, San Francisco, Div. Vascular Surgery and San Francisco VAMC
  • Stanford University Medical Center
  • Yale New Haven School of Med., Dept. of Vascular Surgery
  • University of Florida, Vascular Surgery
  • Massachusetts General Hospital
  • University of Michigan Hospital
  • Spectrum Health Butterworth
  • William Beaumont Hospital
  • Mayo Clinic
  • Barnes-Jewish Hospital
  • Mercy Hospital
  • Morristown Memorial Hospital
  • New York University Hospital
  • New York Presbyterian Hospital - Cornell
  • University of Rochester, Strong Memorial Hospital
  • University of North Carolina
  • Cleveland Clinic
  • Ohio Health Research Institute
  • Hospital of the University of Pennsylvania
  • Allegheny General Hospital
  • Fairfax Inova Hospital
  • Harborview Medical Center
  • St. Luke's Medical Center
  • Queen Mary Hospital
  • St. Franziskus Hospital
  • CELT Hospital
  • Malmo University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

Treatment with Endovascular Graft

Outcomes

Primary Outcome Measures

Patients With Major Adverse Events (MAE)
MAE is defined as any occurrence of all-cause death, Q-wave myocardial infarction (MI), renal failure requiring dialysis, paralysis, stroke, bowel ischemia, or re-intubation.
Patients With Device Failures
Device success at 12-month is defined as: Technical Success (successful access of the aneurysm site, deployment of the graft in the intended location, and patency of the graft at the time of deployment completion intra-operatively), and freedom from the following at 12 months: Type I or type III endoleaks requiring re-intervention, Aneurysm rupture or conversion to open surgical repair, and Aneurysm enlargement greater than 0.5 cm.

Secondary Outcome Measures

Full Information

First Posted
January 30, 2009
Last Updated
March 8, 2018
Sponsor
Cook Group Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00833924
Brief Title
Zenith(R) Low Profile AAA Endovascular Graft Clinical Study
Official Title
Evaluation of the Safety and Effectiveness of the Zenith(R) Low Profile AAA Endovascular Graft
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Group Incorporated

4. Oversight

5. Study Description

Brief Summary
The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft to treat abdominal aortic, aorto-iliac, and iliac aneurysms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysms, Iliac Aneurysms, Aorto-iliac Aneurysms
Keywords
Low Profile, Abdominal Aortic Aneurysms, Endovascular

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Treatment with Endovascular Graft
Intervention Type
Device
Intervention Name(s)
Zenith(R) Low Profile AAA Endovascular Graft
Intervention Description
The Zenith(R) Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
Primary Outcome Measure Information:
Title
Patients With Major Adverse Events (MAE)
Description
MAE is defined as any occurrence of all-cause death, Q-wave myocardial infarction (MI), renal failure requiring dialysis, paralysis, stroke, bowel ischemia, or re-intubation.
Time Frame
30-day
Title
Patients With Device Failures
Description
Device success at 12-month is defined as: Technical Success (successful access of the aneurysm site, deployment of the graft in the intended location, and patency of the graft at the time of deployment completion intra-operatively), and freedom from the following at 12 months: Type I or type III endoleaks requiring re-intervention, Aneurysm rupture or conversion to open surgical repair, and Aneurysm enlargement greater than 0.5 cm.
Time Frame
12-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Abdominal aortic, aortoiliac, and iliac aneurysms of appropriate size Vessels suitable for endovascular access and aneurysm repair Exclusion Criteria: Less than 18 years of age Inability or refusal to give informed consent Disease considerations that would compromise patient safety or study outcomes Unsuitable arterial anatomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Fairman, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco, Div. Vascular Surgery and San Francisco VAMC
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Yale New Haven School of Med., Dept. of Vascular Surgery
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
University of Florida, Vascular Surgery
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Spectrum Health Butterworth
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Mercy Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
New York University Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
New York Presbyterian Hospital - Cornell
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Rochester, Strong Memorial Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27955
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio Health Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Fairfax Inova Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
China
Facility Name
St. Franziskus Hospital
City
Munster
ZIP/Postal Code
48145
Country
Germany
Facility Name
CELT Hospital
City
Moscow
ZIP/Postal Code
111123
Country
Russian Federation
Facility Name
Malmo University Hospital
City
Malmo
Country
Sweden

12. IPD Sharing Statement

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Zenith(R) Low Profile AAA Endovascular Graft Clinical Study

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