Zenith(R) Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Clinical Study

Cook Group Incorporated42 enrolled

Overview

The Zenith(R) Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation approved by the US FDA to study the safety and effectiveness of the Zenith(R) Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic and aorto-iliac aneurysms.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Abdominal Aortic Aneurysms Aorto-iliac Aneurysms Juxtarenal Aneurysms

Interventions

Zenith(R) Fenestrated AAA Endovascular GraftDEVICE

The Zenith(R) Fenestrated AAA Endovascular Graft with the H\&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Abdominal aortic and aortoiliac aneurysms with diameter greater than or equal to 5 cm Exclusion Criteria: * Proximal neck less than 4 mm or greater than or equal to 15 mm in length unless otherwise compromised to preclude seal * Renal artery stenosis greater than 50 percent

Locations (14)

University of California, San Francisco

San Francisco, California, United States

Shands Hospital

Gainesville, Florida, United States

The Indiana Heart Hospital

Outcomes

Primary Outcomes

Number of Participants With Treatment Success

Technical success (successful access, deployment, and patency of the Fenestrated Graft, and patency of all vessels targeted by a fenestration intra-operatively), and freedom from the following: type I or type III endoleaks, AAA-related serious adverse events, AAA-related major complications, and aneurysm enlargement greater than 0.5 cm. A serious adverse event is defined as any occurrence of death, aneurysm rupture, or conversion to open surgical repair. A major complication is defined as any occurrence of Q-wave myocardial infarction, congestive heart failure, cardiac ischemia requiring intervention, renal failure requiring permanent dialysis, bowel obstruction, ischemia, or fistula, stroke with permanent deficit, or paralysis.

Time frame: 6 months

Data from ClinicalTrials.gov

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