Zenith® AAA Endovascular Graft Clinical Study

NCT ID: NCT00196092

Last Updated: 2015-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

819 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2006-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Abdominal Aortic Aneurysm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Roll-in

Group Type OTHER

Roll-in

Intervention Type DEVICE

Proctored entry.

2

Surgical

Group Type OTHER

Surgical

Intervention Type DEVICE

Surgery

3

Standard Risk

Group Type OTHER

Standard Risk

Intervention Type DEVICE

Standard Endovascular repair

4

High Risk

Group Type OTHER

High Risk

Intervention Type DEVICE

High Risk Endovascular repair.

5

Compassionate Use

Group Type OTHER

Compassionate Use

Intervention Type DEVICE

Endovascular repair for compassionate use patients.

6

Treatment for females.

Group Type OTHER

Treatment for females

Intervention Type DEVICE

Endovascular repair in female patients

7

Standard Risk Continued Access

Group Type OTHER

Standard Risk Continued Access

Intervention Type DEVICE

Continued Access Endovascular repair for standard risk patients.

8

High Risk Continued Access

Group Type OTHER

High Risk Continued Access

Intervention Type DEVICE

Continued Access Endovascular Repair for High Risk Patients.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Roll-in

Proctored entry.

Intervention Type DEVICE

Surgical

Surgery

Intervention Type DEVICE

Standard Risk

Standard Endovascular repair

Intervention Type DEVICE

High Risk

High Risk Endovascular repair.

Intervention Type DEVICE

Compassionate Use

Endovascular repair for compassionate use patients.

Intervention Type DEVICE

Treatment for females

Endovascular repair in female patients

Intervention Type DEVICE

Standard Risk Continued Access

Continued Access Endovascular repair for standard risk patients.

Intervention Type DEVICE

High Risk Continued Access

Continued Access Endovascular Repair for High Risk Patients.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cook Group Incorporated

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Roy Greenberg, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

99-514

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Zenith® Low Profile AAA Endovascular Graft
NCT02557659 NO_LONGER_AVAILABLE
Zenith® TX2® Low Profile TAA Endovascular Graft
NCT02471781 APPROVED_FOR_MARKETING