Zenith(R) Low Profile AAA Endovascular Graft Clinical Study

Cook Group Incorporated120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Abdominal Aortic Aneurysms Iliac Aneurysms Aorto-iliac Aneurysms

Interventions

Zenith(R) Low Profile AAA Endovascular GraftDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (27)

Outcomes

Primary Outcomes

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.

Time frame: 30-day

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.

Time frame: 12-month

Data from ClinicalTrials.gov

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University of California, San Francisco, Div. Vascular Surgery and San Francisco VAMC

San Francisco, California, United States

Stanford University Medical Center

Stanford, California, United States

Yale New Haven School of Med., Dept. of Vascular Surgery

New Haven, Connecticut, United States

University of Florida, Vascular Surgery

Gainesville, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Michigan Hospital

Ann Arbor, Michigan, United States

Spectrum Health Butterworth

Grand Rapids, Michigan, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Barnes-Jewish Hospital

St Louis, Missouri, United States

...and 17 more locations