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Zenith® AAA Endovascular Graft Clinical Study

NCT00196092 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 819

Last updated 2015-03-12

No results posted yet for this study

Summary

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.

Conditions

  • Abdominal Aortic Aneurysm

Interventions

DEVICE

Roll-in

Proctored entry.

DEVICE

Surgical

Surgery

DEVICE

Standard Risk

Standard Endovascular repair

DEVICE

High Risk

High Risk Endovascular repair.

DEVICE

Compassionate Use

Endovascular repair for compassionate use patients.

DEVICE

Treatment for females

Endovascular repair in female patients

DEVICE

Standard Risk Continued Access

Continued Access Endovascular repair for standard risk patients.

DEVICE

High Risk Continued Access

Continued Access Endovascular Repair for High Risk Patients.

Sponsors & Collaborators

  • Cook Group Incorporated

    lead INDUSTRY

Principal Investigators

  • Roy Greenberg, M.D. · The Cleveland Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-01-31
Completion
2006-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00196092 on ClinicalTrials.gov