Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta (Zone 0/1)
- Conditions
- Aortic Aneurysm, ThoracicAorta, Lesion
- Interventions
- Device: GORE® TAG® Thoracic Branch EndoprosthesisProcedure: Revascularization Procedure
- Registration Number
- NCT02777528
- Lead Sponsor
- W.L.Gore & Associates
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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)
- Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair
- Previous endovascular repair of the ascending aorta
- Previous endovascular repair of the DTA with a non-Gore device
- Surgery within 30 days prior to enrollment, with the exception of surgery for Ascending Aortic Dissection and/or placement of vascular conduit for access.
- Infected aorta
- Life expectancy <2 years
- Myocardial infarction within 6 weeks prior to treatment
- Stroke within 6 weeks prior to treatment, stroke defined as rapidly developing clinical signs of focal (or global) disturbance of cerebral function, lasting more than 24 hours or leading to death, with no apparent cause other than that of vascular origin.
- Patient has a systemic infection and may be at increased risk of endovascular graft infection
- Pregnant female at time of informed consent signature
- Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
- Participation in another drug or medical device study within one year of study enrollment
- Known history of drug abuse within one year of treatment
- Presence of protruding and/or irregular thrombus and/or atheroma in the aortic arch or ascending aorta
- Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access
- Planned coverage of celiac artery
- Patient has known sensitivities or allergies to the device materials
- Patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment
- Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
- Patient with a history of a hypercoagulability disorder and/or hypercoagulability state
- Diameter taper outside of the device sizing range between proximal and distal landing zones of aorta and the inability to use additional devices of different diameters to compensate for the taper
- Mycotic aneurysm
- Persistent refractory shock (systolic blood pressure <90 mm Hg)
- Patient has body habitus or other medical condition which prevents adequate visualization of the aorta
- Renal failure defined as patients with an estimated Glomerular Filtration Rate (eGFR) <30 or currently requiring dialysis
- Patient at high risk of neurological event, e.g. stroke
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Zone 0/1 Aortic aneurysm Revascularization Procedure Zone 0/1 Aortic aneurysm Zone 0/1 Aortic aneurysm GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Aortic aneurysm Zone 0/1 Non-aneurysm aortic lesions GORE® TAG® Thoracic Branch Endoprosthesis Includes dissection and other isolated lesion types Zone 0/1 Non-aneurysm aortic lesions Revascularization Procedure Includes dissection and other isolated lesion types
- Primary Outcome Measures
Name Time Method Composite of Initiation of Index Procedure, Device Technical Success and Adverse Events for Zone 0/1 Subjects (Aneurysm Cohort) 12 months Composite of the following events through twelve months: initiation of the index endovascular procedure following the debranching procedure, device technical success for the index endovascular procedure and absence of the following Core Lab and adverse events: aortic rupture, lesion related mortality, disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis, additional unanticipated post-procedural surgical or interventional procedure related to the device, procedure, or withdrawal of the delivery system.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (39)
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Keck Medical Center of USC
🇺🇸Los Angeles, California, United States
Cedar-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Leland Stanford Junior University
🇺🇸Stanford, California, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
St. Vincent Medical Group, Inc.
🇺🇸Indianapolis, Indiana, United States
University of Baltimore Maryland
🇺🇸Baltimore, Maryland, United States
Washington Univeristy School of Medicine - St Louis
🇺🇸Saint Louis, Missouri, United States
Dartmouth-Hitchock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
Cardiovascular Surgery Clinic
🇺🇸Memphis, Tennessee, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Memorial Hermann
🇺🇸Houston, Texas, United States
Heart Hospital at Baylor Plano
🇺🇸Plano, Texas, United States
Nagoya University Hospital
🇯🇵Aichi, Japan
Oita University Hospital
🇯🇵Oita, Japan
Morinomiya Hospital
🇯🇵Osaka, Japan
Osaka University Hospital
🇯🇵Osaka, Japan
Jikei Medical University Hospital
🇯🇵Tokyo, Japan
Emory University
🇺🇸Atlanta, Georgia, United States
Northwesten University
🇺🇸Chicago, Illinois, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Carolinas HealthCare Systems
🇺🇸Charlotte, North Carolina, United States
Research Foundation SUNY Buffalo
🇺🇸Buffalo, New York, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Baylor College of Medicine - Houston
🇺🇸Houston, Texas, United States
University of Washington
🇺🇸Seattle, Washington, United States
Sentara Medical Group
🇺🇸Norfolk, Virginia, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Florida-Gainesville
🇺🇸Gainesville, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Cardiothoracic and Vascular Surgeons
🇺🇸Austin, Texas, United States
University of Wisconsin System
🇺🇸Madison, Wisconsin, United States