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Zenith(R) Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Clinical Study
This study is currently recruiting participants.
Verified October 2011 by Cook

First Received on February 19, 2009.   Last Updated on October 13, 2011   History of Changes
Sponsor: Cook
Information provided by (Responsible Party): Cook
ClinicalTrials.gov Identifier: NCT00875563
  Purpose

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.


Condition Intervention
Abdominal Aortic Aneurysms
Aorto-iliac Aneurysms
Juxtarenal Aneurysms
 Device: Zenith(R) Fenestrated AAA Endovascular Graft

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Effectiveness of the Zenith(R) Fenestrated AAA Endovascular Graft

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms Aortic Aneurysm
U.S. FDA Resources

Further study details as provided by Cook:

Primary Outcome Measures:
  • Treatment Success [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Technical success (successful access, deployment, and patency of the Fenestrated Graft, and patency of vessels targeted by a fenestration intra-operatively), no type I or type III endoleaks, no AAA-related serious adverse events or major complications, and no aneurysm enlargement greater than 0.5 cm.


Estimated Enrollment: 82
Study Start Date: January 2005
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Endovascular Repair
 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00875563

Contacts
Contact: Rachel Bell, PhD, RAC 800-356-9208 rbell@medinst.com

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Linda M. Reilly, MD     415-353-4366     reillyl@surgery.ucsf.edu    
United States, Florida
University of Florida Withdrawn
Gainesville, Florida, United States, 32610
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Christopher Kwolek     617-724-6101        
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Gustavo Oderich, MD     507-255-7208     Oderich.gustavo@mayo.edu    
United States, Missouri
Barnes-Jewish Hospital Recruiting
St. Louis, Missouri, United States, 63110
Contact: Gregorio Sicard     314-362-7841        
United States, New York
NYU Medical Center Recruiting
New York, New York, United States, 10016
Contact: Neal Cayne, MD     212-263-7311     neal.cayne.@med.nyu.edu    
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Mark Farber     919-966-3391        
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Sean Lyden     216-444-3581        
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Ronald M. Fairman, MD, FACS     215-614-0308     ron.fairman@uphs.upenn.edu    
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Michel S. Makaroun, MD     412-802-3028     makarounms@upmc.edu    
United States, Washington
Harborview Medical Center Not yet recruiting
Seattle, Washington, United States, 98104
Contact: Benjamin Starnes, MD     206-744-3370     starnes@u.washington.edu    
Sponsors and Collaborators
Cook
Investigators
Study Director: Roy Greenberg, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT00875563     History of Changes
Other Study ID Numbers: 04-541, 370015, FNCT
Study First Received: February 19, 2009
Last Updated: October 13, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Iliac Aneurysm
Aortic Aneurysm, Abdominal
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on February 09, 2012



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