Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms
Condition(s) studied
Investigational drug(s) / intervention(s)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
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)
Eligibility
Primary outcome measure(s)
- Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event — From start of Index Procedure to 59 Days Post Procedure
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 Disabling Stroke - Percent of Subjects Free From Clinically Significant Reintervention / Lesion-Related Mortality — 12 Months
Composite Outcome of Lesions-Related Mortality and Clinically Significant Reinterventions through 12 Months for Pre-defined Reasons.
Trial sites (44)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | |
| Mayo Clinic Arizona | Scottsdale | Arizona | |
| Keck Medical Center of USC | Los Angeles | California | |
| Cedars-Sinai Medical Center | Los Angeles | California | |
| Kaiser Permanente San Francisco Medical Center | San Francisco | California | |
| Stanford University | Stanford | California | |
| MedStar Health Research Institute - MedStar Washington Hospital | Washington D.C. | District of Columbia | |
| University of Florida - Gainesville | Gainesville | Florida | |
| University of South Florida | Tampa | Florida | |
| Emory University Hospital | Atlanta | Georgia | |
| Northwestern University | Chicago | Illinois | |
| Indiana University | Indianapolis | Indiana | |
| University of Maryland Medical Center | Baltimore | Maryland | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| University of Michigan - Cardiac Surgery | Ann Arbor | Michigan | |
| Essentia Health | Duluth | Minnesota | |
| Division of Vascular Surgery - Minneapolis Heart Institute | Minneapolis | Minnesota | |
| Mayo Clinic - Rochester | Rochester | Minnesota | |
| Washington University School of Medicine | St Louis | Missouri | |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | |
| Mount Sinai West | New York | New York | |
| Weill Cornell Medical Center | New York | New York | |
| University of Rochester | Rochester | New York | |
| University of North Carolina | Chapel Hill | North Carolina | |
| Sanger Heart & Vascular Institute | Charlotte | North Carolina | |
| Duke University Medical Center | Durham | North Carolina | |
| Cleveland Clinic | Cleveland | Ohio | |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | |
| University of Pennsylvania | Philadelphia | Pennsylvania | |
| UPP Heart and Vascular Institute | Pittsburgh | Pennsylvania | |
| University of Tennessee -University Vascular Surgeons | Knoxville | Tennessee | |
| St. David's Healthcare | Austin | Texas | |
| Baylor Heart & Vascular Hospital | Dallas | Texas | |
| University of Texas Southwestern | Dallas | Texas | |
| Baylor College of Medicine | Houston | Texas | |
| The Methodist Hospital - Houston | Houston | Texas | |
| University of Texas Health Science Center | Houston | Texas | |
| Sentara Medical Group | Norfolk | Virginia | |
| Carilion Clinic Hospitals | Roanoke | Virginia | |
| University of Washington | Seattle | Washington |
+ 4 more sites — see the full list on the official registry below.
More W.L.Gore & Associates trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03728985 on ClinicalTrials.gov ↗ ← All trials in the UK