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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 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.
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)
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03728985
The ClinicalTrials.gov registry entry for NCT03728985 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 191-participant average among 11 other Thoracoabdominal Aortic Aneurysm trials with a reported enrollment target (47% lower). The listed sponsor is W.L.Gore & Associates, which has 53 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.