Zenith® AAA Endovascular Graft Clinical Study

March 11, 2015 updated by: Cook Group Incorporated
The purpose of this study is to evaluate the safety and effectiveness of the Cook Zenith Endovascular Graft for the treatment of abdominal aortic (AAA), aortoiliac, and iliac aneurysms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

819

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with an aortic or aortoiliac aneurysm with diameter greater than or equal to 4 cm.
  2. Patients with an iliac aneurysm with diameter greater than or equal to 3.5 cm.
  3. Patients with an aortic, aortoiliac, or iliac aneurysm with a history of growth greater than or equal to 0.5 cm per year.

Exclusion Criteria:

  1. Patients less than 18 years of age.
  2. Patient with a life expectancy less than 2 years.
  3. Patients who are pregnant.
  4. Patients unwilling to comply with the follow-up schedule.
  5. Patient inability or refusal to give informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 2
Surgical
Device: Surgical
Surgery
Other: 1
Roll-in
Device: Roll-in
Proctored entry.
Other: 3
Standard Risk
Device: Standard Risk
Standard Endovascular repair
Other: 4
High Risk
Device: High Risk
High Risk Endovascular repair.
Other: 5
Compassionate Use
Device: Compassionate Use
Endovascular repair for compassionate use patients.
Other: 6
Treatment for females.
Device: Treatment for females
Endovascular repair in female patients
Other: 7
Standard Risk Continued Access
Device: Standard Risk Continued Access
Continued Access Endovascular repair for standard risk patients.
Other: 8
High Risk Continued Access
Device: High Risk Continued Access
Continued Access Endovascular Repair for High Risk Patients.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Group Incorporated

Investigators

  • Principal Investigator: Roy Greenberg, M.D., The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

March 12, 2015

Last Update Submitted That Met QC Criteria

March 11, 2015

Last Verified

December 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 99-514

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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