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NCT02489539 · ClinicalTrials.gov registry record · NA
Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms
A NA study of Aortic Aneurysm, Abdominal, sponsored by W.L.Gore & Associates.
- Active
- Registry status
- NA
- Development phase
- 175
- Enrollment target
- 20
- Study locations
NCT02489539: Active NA study of Aortic Aneurysm, Abdominal, sponsored by W.L.Gore & Associates.
NCT02489539 is a NA study of Aortic Aneurysm, Abdominal that is active but no longer recruiting, run by W.L.Gore & Associates. The registered enrollment target is 175 participants, above the 133-participant average among 8 other Aortic Aneurysm, Abdominal trials with a reported enrollment target (32% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02489539, a NA study of Aortic Aneurysm, Abdominal, is active but no longer recruiting, sponsored by W.L.Gore & Associates.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 175 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study is to assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis to treat an infrarenal aneurysm located in the abdominal aorta. Performance of the GORE® EXCLUDER® Conformable AAA Endoprosthesis will be judged by separate performance goals.
Primary Outcome
The primary safety endpoint event includes a composite of the following: * Death * Stroke * Myocardial Infarction * Bowel Ischemia * Paraplegia * Respiratory Failure * Renal Failure * Procedural Blood Loss \> 1000 mL * Thromboembolic events (including limb occlusion and distal embolic events)
Conditions Studied
Interventions
- DEVICE GORE® EXCLUDER® Conformable AAA Endoprosthesis
Study Locations (20)
Florida
- River City Clinical Research - Jacksonville
- Baptist Cardiac and Vascular Institute - Miami
- Florida Hospital - Orlando
- Sarasota Vascular Specialists - Sarasota
Minnesota
- Essentia Institute of Rural Health - Duluth
- Minneapolis Heart Institute Foundation - Abbott Northwestern Hospital - Minneapolis
- Minneapolis Radiology and Vascular Research Foundation - Plymouth
- Mayo Clinic - Rochester - Rochester
California
- University of Southern California - Los Angeles
- Leland Stanford Junior University - Stanford
Georgia
- Emory University - Atlanta
- Vascular Surgical Associates, PC - Marietta
Illinois
- Loyola University - Chicago - Maywood
- Southern Illinois University - Springfield
Michigan
- University of Michigan - Ann Arbor
- Spectrum Health System - Grand Rapids
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Mayo Clinic Arizona - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2017-12-19 |
| Est. Completion | 2027-12-31 |
| Phase | NA |
What the registry record for NCT02489539 still lists
NCT02489539 is an interventional study that assigns participants to a tested intervention. The registered 175 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 8 other Aortic Aneurysm, Abdominal trials with a reported enrollment target (32% higher).
The record links to 1 condition, with Aortic Aneurysm, Abdominal appearing as the primary indexed condition, and to 1 intervention - of which GORE® EXCLUDER® Conformable AAA Endoprosthesis is the first listed.
NCT02489539 names 20 study sites across 10 states, led by Florida, Minnesota, California.
Frequently Asked Questions
What is clinical trial NCT02489539 about?
NCT02489539 is a clinical study titled "Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms". The purpose of the study is to assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis to treat an infrarenal aneurysm located in the abdominal aorta. Performance of the GORE® EXCLUDER® Conformable AAA Endoprosthesis will be judged by separate performance goals.
What is the current status of trial NCT02489539?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 175 participants. The study started on 2017-12-19. Estimated completion is 2027-12-31.
What conditions does trial NCT02489539 study?
This clinical trial studies the following conditions: Aortic Aneurysm, Abdominal.
What interventions are being tested in trial NCT02489539?
The interventions under investigation include: GORE® EXCLUDER® Conformable AAA Endoprosthesis (DEVICE).
Who is sponsoring clinical trial NCT02489539?
This trial is sponsored by W.L.Gore & Associates, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02489539 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02489539's enrollment target sits among peer trials
175 4th of 8 higher than 5 of 8 other Aortic Aneurysm, Abdominal trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aortic Aneurysm, Abdominal trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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