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NCT00875563 · ClinicalTrials.gov registry record · NA
Zenith(R) Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Clinical Study
A NA study of Abdominal Aortic Aneurysms and Aorto-iliac Aneurysms, sponsored by Cook Group Incorporated.
- Completed
- Registry status
- NA
- Development phase
- 42
- Enrollment target
- 14
- Study locations
NCT00875563: Completed NA study of Abdominal Aortic Aneurysms and Aorto-iliac Aneurysms, sponsored by Cook Group Incorporated.
NCT00875563 is a NA study of Abdominal Aortic Aneurysms and Aorto-iliac Aneurysms that has completed, run by Cook Group Incorporated. The registered enrollment target is 42 participants, below the 195-participant average among 5 other Abdominal Aortic Aneurysms trials with a reported enrollment target (78% lower). The trial reports 14 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00875563, a NA study of Abdominal Aortic Aneurysms and Aorto-iliac Aneurysms, has completed, sponsored by Cook Group Incorporated.
- COMPLETED
- Registry status
- NA
- Development phase
- 42 participants
- Enrollment target
- 14
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DEVICE Zenith(R) Fenestrated AAA Endovascular Graft
Study Locations (14)
Massachusetts
- Massachusetts General Hospital - Boston
- University of Massachusetts - Worcester
Pennsylvania
- Hospital of the University of Pennsylvania - Philadelphia
- University of Pittsburgh Medical Center - Pittsburgh
California
- University of California, San Francisco - San Francisco
Florida
- Shands Hospital - Gainesville
Indiana
- The Indiana Heart Hospital - Indianapolis
Minnesota
- Mayo Clinic - Rochester
Missouri
- Barnes-Jewish Hospital - St Louis
New Hampshire
- Dartmouth Hitchcock Medical Center - Lebanon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2005-01 |
| Est. Completion | 2015-09 |
| Phase | NA |
What the finished NCT00875563 record still lists
NCT00875563 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 195-participant average among 5 other Abdominal Aortic Aneurysms trials with a reported enrollment target (78% lower).
The record links to 3 conditions, with Abdominal Aortic Aneurysms appearing as the primary indexed condition, and to 1 intervention - of which Zenith(R) Fenestrated AAA Endovascular Graft is the first listed.
NCT00875563 lists 14 locations in 12 states (Massachusetts, Pennsylvania, California).
Frequently Asked Questions
What is clinical trial NCT00875563 about?
NCT00875563 is a clinical study titled "Zenith(R) Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Clinical Study". 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.
What is the current status of trial NCT00875563?
This trial is currently completed. It is a NA study. The enrollment target is 42 participants. The study started on 2005-01. Estimated completion is 2015-09.
What conditions does trial NCT00875563 study?
This clinical trial studies the following conditions: Abdominal Aortic Aneurysms, Aorto-iliac Aneurysms, Juxtarenal Aneurysms.
What interventions are being tested in trial NCT00875563?
The interventions under investigation include: Zenith(R) Fenestrated AAA Endovascular Graft (DEVICE).
Who is sponsoring clinical trial NCT00875563?
This trial is sponsored by Cook Group Incorporated, which has 31 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00875563 being conducted?
This trial has 14 study locations across California, Florida, Indiana, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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