Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of the Thoracoabdominal and Pararenal Aortic Aneurysms (TAMBE)

Thoracoabdominal Aneurysm Clinical Trial

— TAMBE  

Official title:

Evaluation of the GORE® EXCLUDER® Thoracoabdominal BranchTreatment of the Thoracoabdominal and Pararenal Aortic Aneurysms (TAMBE)

Clinical Trial Details — Status: Available

Administrative data

• NCT number: NCT05442489
• Other study ID #: AAA 17-01 Expanded Access
• Status: Available

Study information

• Verified date: August 2023
• Source: W.L.Gore & Associates
• Contact: Sarah Rosbach
• Phone: 800-437-8181
• Email: AAA1701[@]wlgore.com
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial Summary

Expanded access tothe GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis is safe and effective in the treatment of thoracoabdominal and pararenal aneurysms.

Description:

Gore will permit the use of the TAMBE Device in a manner consistent with the approved CIP provided that its use is needed to treat a serious, but non-life-threatening condition. In the requesting physician's opinion, there must be no acceptable alternative treatment option. Patients are to be consented with an Emergency / Compassionate Use ICF template provided by Gore upon request for this type of device use. Sites will be required to fill out a packet justifying the rationale of use as well as their plan to conduct follow-up surveillance on the non-study subject. Upon performance of the case, the site will immediately notify Gore and provide supporting documentation to facilitate timely, compliant regulatory reporting.

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• Gender: All
• Age group: 19 Years and older

Eligibility

• Aortic aneurysm involving the visceral vessels requiring treatment defined as at least one of the following: Fusiform aneurysm diameter = 5 cm Saccular aneurysm (no diameter requirement) Rapid aneurysm growth (= 5 mm in one year)

• An Informed Consent Form signed by Subject or legal representative

• Appropriate aortic anatomy to receive the TAMBE Device d

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Thoracoabdominal Aneurysm

Intervention

Device:
• GORE Excluder Thoracoabdominal Branch Endoprosthesis
TEVAR

Locations

Country	Name	City	State
United States	University of Michigan - Cardiac Surgery	Ann Arbor	Michigan
United States	Emory University Hospital	Atlanta	Georgia
United States	Cardiothoracic and Vascular Surgeons, PA (CTVS)	Austin	Texas
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Sanger Heart & Vascular Institute	Charlotte	North Carolina
United States	Northwestern University	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Baylor Heart & Vascular Hospital	Dallas	Texas
United States	University of Texas Southwestern	Dallas	Texas
United States	Essentia Health	Duluth	Minnesota
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Florida - Gainesville	Gainesville	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	The Methodist Hospital - Houston	Houston	Texas
United States	University of Texas Health Science Center	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	University of Tennessee -University Vascular Surgeons	Knoxville	Tennessee
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Keck Medical Center of USC	Los Angeles	California
United States	University of Wisconsin - Madison	Madison	Wisconsin
United States	Aurora Health Care, Metro Inc.	Milwaukee	Wisconsin
United States	Division of Vascular Surgery - Minneapolis Heart Institute	Minneapolis	Minnesota
United States	Mount Sinai West	New York	New York
United States	Weill Cornell Medical Center	New York	New York
United States	Sentara Medical Group	Norfolk	Virginia
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	UPP Heart and Vascular Institute	Pittsburgh	Pennsylvania
United States	Carilion Clinic Hospitals	Roanoke	Virginia
United States	Mayo Clinic - Rochester	Rochester	Minnesota
United States	University of Rochester	Rochester	New York
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Kaiser Permanente San Francisco Medical Center	San Francisco	California
United States	Mayo Clinic Arizona	Scottsdale	Arizona
United States	University of Washington	Seattle	Washington
United States	Stanford University	Stanford	California
United States	University of South Florida	Tampa	Florida
United States	MedStar Health Research Institute - MedStar Washington Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

United States,