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

Not Applicable

Completed

• Conditions: Abdominal Aortic Aneurysms; Aorto-iliac Aneurysms; Juxtarenal Aneurysms
• Interventions: Device: Zenith(R) Fenestrated AAA Endovascular Graft

• Registration Number: NCT00875563
• Lead Sponsor: Cook Group Incorporated

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2009-02-19
• Study First Submitted QC: 2009-04-02
• Study First Posted: 2009-04-03
• Primary Completion: 2011-02
• Results First Submitted: 2015-06-30
• Results First Submitted QC: 2015-08-31
• Study Completion: 2015-09
• Results First Posted: 2015-09-30
• Status Verified: 2016-03
• Last Update Submitted: 2016-11-20
• Last Update Posted: 2017-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Zenith(R) Fenestrated AAA Endovascular Graft	Zenith(R) Fenestrated AAA Endovascular Graft

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Success	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.

Trial Locations

Locations (14)

Barnes-Jewish Hospital; 🇺🇸 St. Louis, Missouri, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Shands Hospital; 🇺🇸 Gainesville, Florida, United States

The Indiana Heart Hospital; 🇺🇸 Indianapolis, Indiana, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Massachusetts; 🇺🇸 Worcester, Massachusetts, United States

Dartmouth Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

NYU Medical Center; 🇺🇸 New York, New York, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States