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NCT00875563 Clinical Trial

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

Abdominal Aortic Aneurysms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00875563
Other study ID # 04-541
Secondary ID 370015, FNCT
Status Completed
Phase N/A
First received February 19, 2009
Last updated March 7, 2016
Start date January 2005
Est. completion date September 2015

Study information
Verified date March 2016
Source Cook
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date September 2015
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Zenith(R) Fenestrated AAA Endovascular Graft
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

Locations
Country Name City State
United States Massachusetts General Hospital Boston Massachusetts
United States University of North Carolina Chapel Hill North Carolina
United States Cleveland Clinic Cleveland Ohio
United States Shands Hospital Gainesville Florida
United States The Indiana Heart Hospital Indianapolis Indiana
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States NYU Medical Center New York New York
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Mayo Clinic Rochester Minnesota
United States University of California, San Francisco San Francisco California
United States Harborview Medical Center Seattle Washington
United States Barnes-Jewish Hospital St. Louis Missouri
United States University of Massachusetts Worcester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Cook

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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.		 6 months Yes
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