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

This study has been completed.
Information provided by (Responsible Party):
Cook Group Incorporated Identifier:
First received: February 19, 2009
Last updated: November 20, 2016
Last verified: March 2016
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

Access to an investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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:

Further study details as provided by Cook Group Incorporated:

Primary Outcome Measures:
  • 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.

Enrollment: 42
Study Start Date: January 2005
Study Completion Date: September 2015
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Zenith(R) Fenestrated AAA Endovascular Graft
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00875563

United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Florida
Shands Hospital
Gainesville, Florida, United States, 32610
United States, Indiana
The Indiana Heart Hospital
Indianapolis, Indiana, United States, 46250
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
University of Massachusetts
Worcester, Massachusetts, United States, 01655
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Barnes-Jewish Hospital
St. Louis, Missouri, United States, 63110
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
NYU Medical Center
New York, New York, United States, 10016
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Cook Group Incorporated
  More Information

Additional Information:
Responsible Party: Cook Group Incorporated Identifier: NCT00875563     History of Changes
Other Study ID Numbers: 04-541
370015, FNCT
Study First Received: February 19, 2009
Results First Received: June 30, 2015
Last Updated: November 20, 2016

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Iliac Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases processed this record on September 21, 2017