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

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.

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Key information

Conditions

Abdominal Aortic Aneurysms Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Aorto-iliac Aneurysms Cardiovascular Diseases Juxtarenal Aneurysms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco, San Francisco, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zenith(R) Fenestrated AAA Endovascular Graft

Device

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

Primary outcomes

Number of Participants With Treatment Success

Time frame: 6 months

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.

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Official study title

Evaluation of the Safety and Effectiveness of the Zenith(R) Fenestrated AAA Endovascular Graft

Important dates

Study start: 2005
Primary completion: 2011
Study completion: 2015
First posted: Apr 3, 2009
Registry last updated: Jan 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed