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NCT03728985 · ClinicalTrials.gov registry record · NA
Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms
A NA study of Thoracoabdominal Aortic Aneurysm, sponsored by W.L.Gore & Associates.
- Active
- Registry status
- NA
- Development phase
- 102
- Enrollment target
- 20
- Study locations
NCT03728985: Active NA study of Thoracoabdominal Aortic Aneurysm, sponsored by W.L.Gore & Associates.
NCT03728985 is a NA study of Thoracoabdominal Aortic Aneurysm that is active but no longer recruiting, run by W.L.Gore & Associates. The registered enrollment target is 102 participants, below the 191-participant average among 11 other Thoracoabdominal Aortic Aneurysm trials with a reported enrollment target (47% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03728985, a NA study of Thoracoabdominal Aortic Aneurysm, is active but no longer recruiting, sponsored by W.L.Gore & Associates.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 102 participants
- Enrollment target
- 20
- Study locations
Study Summary
Prospective, non-randomized, , multicenter study with two independent arms: * Primary Study Arm - TAAA and Pararenal aneurysms requiring only TAMBE System. Hypothesis-driven analysis. * Up to 65 additional subjects may be implanted in Continued Access Phase under the Primary Study Arm only * Secondary Study Arm - TAAA requiring TAMBE System and CTAG Device(s). Non hypothesis-driven analysis. Minimum: 122 implanted subjects. Maximum: 202 implanted subjects with up to 65 additional subjects implanted in Continued Access (Primary Study arm)
Primary Outcome
Percent of Subjects with Device Technical Success Composite Event and freedom from Procedural Safety Composite Event. Device Technical Success Composite Events during Index Procedure: Successful Access and Delivery Successful and Accurate Deployment Successful Withdrawal Procedural Safety during 30 days of Index Procedure: Stented Segment Aortic Rupture Lesion-Related Mortality Permanent Paraplegia Permanent Paraparesis New Onset Renal Failure Requiring Dialysis Severe Bowel Ischemia Disabli
Conditions Studied
Interventions
- DEVICE GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
Study Locations (20)
California
- Keck Medical Center of USC - Los Angeles
- Cedars-Sinai Medical Center - Los Angeles
- Kaiser Permanente San Francisco Medical Center - San Francisco
- Stanford University - Stanford
Minnesota
- Essentia Health - Duluth
- Division of Vascular Surgery - Minneapolis Heart Institute - Minneapolis
- Mayo Clinic - Rochester - Rochester
Florida
- University of Florida - Gainesville - Gainesville
- University of South Florida - Tampa
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Mayo Clinic Arizona - Scottsdale
District of Columbia
- MedStar Health Research Institute - MedStar Washington Hospital - Washington D.C.
Georgia
- Emory University Hospital - Atlanta
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2019-06-17 |
| Est. Completion | 2030-01 |
| Phase | NA |
What the registry record for NCT03728985 still lists
NCT03728985 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 191-participant average among 11 other Thoracoabdominal Aortic Aneurysm trials with a reported enrollment target (47% lower).
The record links to 1 condition, with Thoracoabdominal Aortic Aneurysm appearing as the primary indexed condition, and to 1 intervention - of which GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis is the first listed.
NCT03728985 names 20 study sites across 14 states, led by California, Minnesota, Florida.
Frequently Asked Questions
What is clinical trial NCT03728985 about?
NCT03728985 is a clinical study titled "Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms". Prospective, non-randomized, , multicenter study with two independent arms: * Primary Study Arm - TAAA and Pararenal aneurysms requiring only TAMBE System. Hypothesis-driven analysis. * Up to 65 additional subjects may be implanted in Continued Access Phase under the Primary Study Arm only * Sec...
What is the current status of trial NCT03728985?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 102 participants. The study started on 2019-06-17. Estimated completion is 2030-01.
What conditions does trial NCT03728985 study?
This clinical trial studies the following conditions: Thoracoabdominal Aortic Aneurysm.
What interventions are being tested in trial NCT03728985?
The interventions under investigation include: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (DEVICE).
Who is sponsoring clinical trial NCT03728985?
This trial is sponsored by W.L.Gore & Associates, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03728985 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03728985's enrollment target sits among peer trials
102 6th of 11 higher than 6 of 11 other Thoracoabdominal Aortic Aneurysm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Thoracoabdominal Aortic Aneurysm 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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