Zenith(R) Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Clinical Study
Evaluation of the Safety and Effectiveness of the Zenith(R) Fenestrated AAA Endovascular Graft
2 other identifiers
interventional
42
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2005
Longer than P75 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 19, 2009
CompletedFirst Posted
Study publicly available on registry
April 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
September 30, 2015
CompletedJanuary 11, 2017
March 1, 2016
6.1 years
February 19, 2009
June 30, 2015
November 20, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
1
EXPERIMENTALZenith(R) Fenestrated AAA Endovascular Graft
Interventions
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 Criteria
You may qualify if:
- Abdominal aortic and aortoiliac aneurysms with diameter greater than or equal to 5 cm
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
University of California, San Francisco
San Francisco, California, 94143, United States
Shands Hospital
Gainesville, Florida, 32610, United States
The Indiana Heart Hospital
Indianapolis, Indiana, 46250, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Massachusetts
Worcester, Massachusetts, 01655, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
NYU Medical Center
New York, New York, 10016, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Scott Snyder, PhD, Director of Clinical Science & Biostatistics
- Organization
- Cook Research Incorporated
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
February 19, 2009
First Posted
April 3, 2009
Study Start
January 1, 2005
Primary Completion
February 1, 2011
Study Completion
September 1, 2015
Last Updated
January 11, 2017
Results First Posted
September 30, 2015
Record last verified: 2016-03