Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta

Status: Active_not_recruiting
Location: See all (39) locations...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Presence of thoracic aortic pathology deemed to warrant surgical repair which requires proximal graft placement in Zone 0-2.

• Age ≥18 years at time of informed consent signature

• Subject is capable of complying with protocol requirements, including follow-up

• Informed Consent Form (ICF) is signed by Subject or legal representative

• Must have appropriate proximal aortic landing zone.

• Must have appropriate target branch vessel landing zone.

• For patients with aneurysm/isolated lesion, must have appropriate distal aortic landing zone.

• Native aortic valve (Zone 0/1 subjects only)

• Subject is considered a high risk candidate for conventional open surgical repair at the discretion of the Investigator (Zone 0/1 subjects only)

Locations
United States
California
Cedar-Sinai Medical Center
Los Angeles
Keck Medical Center of USC
Los Angeles
Leland Stanford Junior University
Stanford
Connecticut
Hartford Hospital
Hartford
Washington, D.c.
MedStar Washington Hospital Center
Washington
Florida
University of Florida-Gainesville
Gainesville
University of South Florida
Tampa
Georgia
Emory University
Atlanta
Illinois
Northwesten University
Chicago
Indiana
St. Vincent Medical Group, Inc.
Indianapolis
Massachusetts
Massachusetts General Hospital
Boston
Maryland
University of Baltimore Maryland
Baltimore
Michigan
University of Michigan
Ann Arbor
Minnesota
Mayo Clinic
Rochester
Missouri
Washington Univeristy School of Medicine - St Louis
Saint Louis
North Carolina
Carolinas HealthCare Systems
Charlotte
Duke University Medical Center
Durham
New Hampshire
Dartmouth-Hitchock Medical Center
Lebanon
New Jersey
Cooper University Hospital
Camden
New York
Research Foundation SUNY Buffalo
Buffalo
Ohio
Cleveland Clinic
Cleveland
Oregon
Oregon Health & Science University
Portland
Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia
University of Pittsburgh Medical Center
Pittsburgh
Tennessee
Cardiovascular Surgery Clinic
Memphis
Vanderbilt University Medical Center
Nashville
Texas
Cardiothoracic and Vascular Surgeons
Austin
Baylor College of Medicine - Houston
Houston
Houston Methodist Hospital
Houston
Memorial Hermann
Houston
Heart Hospital at Baylor Plano
Plano
Virginia
Sentara Medical Group
Norfolk
Washington
University of Washington
Seattle
Wisconsin
University of Wisconsin System
Madison
Other Locations
Japan
Nagoya University Hospital
Aichi
Oita University Hospital
Oita
Morinomiya Hospital
Osaka
Osaka University Hospital
Osaka
Jikei Medical University Hospital
Tokyo
Time Frame
Start Date: 2016-08
Completion Date: 2028-03
Participants
Target number of participants: 150
Treatments
Other: Zone 0/1 Aortic aneurysm
Zone 0/1 Aortic aneurysm
Other: Zone 0/1 Non-aneurysm aortic lesions
Includes dissection and other isolated lesion types
Related Therapeutic Areas
Sponsors
Leads: W.L.Gore & Associates

This content was sourced from clinicaltrials.gov