Zenith® AAA Endovascular Graft Clinical Study

N/ACompletedNCT00196092

Cook Group Incorporated819 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

819

Conditions

Abdominal Aortic Aneurysm

Interventions

Roll-inDEVICE

Proctored entry.

SurgicalDEVICE

Surgery

Standard RiskDEVICE

Standard Endovascular repair

High Risk

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Data from ClinicalTrials.gov

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