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Clinical Trials in Japan / NCT02777528
Active, not recruiting Not applicable

Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 0/1

NCT02777528 · tracked via the Priya Life Science Japan tracker
Phase
Not applicable
Started
2016-08
Last updated
2026-09-10

Condition(s) studied

Aortic Aneurysm, ThoracicAorta, Lesion

Investigational drug(s) / intervention(s)

GORE® TAG® Thoracic Branch EndoprosthesisRevascularization Procedure

GORE® TAG® Thoracic Branch Endoprosthesis: Endovascular repair with the TBE Device

Revascularization Procedure: Revascularization procedure of the great vessel

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Presence of thoracic aortic pathology deemed to warrant surgical repair which requires proximal graft placement in Zone 0-2. 2. Age ≥18 years at time of informed consent signature 3. Subject is capable of complying with protocol requirements, including follow-up 4. Informed Consent Form (ICF) is signed by Subject or legal representative 5. Must have appropriate proximal aortic landing zone. 6. Must have appropriate target branch vessel landing zone. 7. For patients with aneurysm/isolated lesion, must have appropriate distal aortic landing zone. 8. Native aortic valve (Zone 0/1 subjects only) 9. Subject is considered a high risk candidate for conventional open surgical repair at the discretion of the Investigator (Zone 0/1 subjects only) Exclusion Criteria: 1. Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair 2. Previous endovascular repair of the ascending aorta 3. Previous endovascular repair of the DTA with a non-Gore device 4. Surgery within 30 days prior to enrollment, with the exception of surgery for Ascending Aortic Dissection and/or placement of vascular conduit for access. 5. Infected aorta 6. Life expectancy \<2 years 7. Myocardial infarction within 6 weeks prior to treatment 8. 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. 9. Patient has a systemic infection and may be at increased risk of endovascular graft infection 10. Pregnant female at time of informed consent signature 11. Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome 12. Participation in another drug or medical device study within one year of study enrollment 13. Known history of drug abuse within one year of treatment 14. Presence of protruding and/or irregular thrombus and/or atheroma in the aortic arch or ascending aorta 15. Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access 16. Planned coverage of celiac artery 17. Patient has known sensitivities or allergies to the device materials 18. Patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment 19. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin 20. Patient with a history of a hypercoagulability disorder and/or hypercoagulability state 21. 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 22. Mycotic aneurysm 23. Persistent refractory shock (systolic blood pressure \<90 mm Hg) 24. Patient has body habitus or other medical condition which prevents adequate visualization of the aorta 25. Renal failure defined as patients with an estimated Glomerular Filtration Rate (eGFR) \<30 or currently requiring dialysis 26. Patient at high risk of neurological event, e.g. stroke

Primary outcome measure(s)

Trial sites (39)

FacilityCityRegionStatus
Keck Medical Center of USC Los Angeles California
Cedar-Sinai Medical Center Los Angeles California
Leland Stanford Junior University Stanford California
Hartford Hospital Hartford Connecticut
MedStar Washington Hospital Center Washington D.C. District of Columbia
University of Florida-Gainesville Gainesville Florida
University of South Florida Tampa Florida
Emory University Atlanta Georgia
Northwesten University Chicago Illinois
St. Vincent Medical Group, Inc. Indianapolis Indiana
University of Baltimore Maryland Baltimore Maryland
Massachusetts General Hospital Boston Massachusetts
University of Michigan Ann Arbor Michigan
Mayo Clinic Rochester Minnesota
Washington Univeristy School of Medicine - St Louis St Louis Missouri
Dartmouth-Hitchock Medical Center Lebanon New Hampshire
Cooper University Hospital Camden New Jersey
Research Foundation SUNY Buffalo Buffalo New York
Carolinas HealthCare Systems Charlotte North Carolina
Duke University Medical Center Durham North Carolina
Cleveland Clinic Cleveland Ohio
Oregon Health & Science University Portland Oregon
Hospital of the University of Pennsylvania Philadelphia Pennsylvania
University of Pittsburgh Medical Center Pittsburgh Pennsylvania
Cardiovascular Surgery Clinic Memphis Tennessee
Vanderbilt University Medical Center Nashville Tennessee
Cardiothoracic and Vascular Surgeons Austin Texas
Baylor College of Medicine - Houston Houston Texas
Houston Methodist Hospital Houston Texas
Memorial Hermann Houston Texas
Heart Hospital at Baylor Plano Plano Texas
Sentara Medical Group Norfolk Virginia
University of Washington Seattle Washington
University of Wisconsin System Madison Wisconsin
Nagoya University Hospital Aichi Japan
Morinomiya Hospital Osaka Japan
Osaka University Hospital Osaka Japan
Oita University Hospital Ōita Japan
Jikei Medical University Hospital Tokyo Japan

More W.L.Gore & Associates trials in Japan

Other trials for the same condition

Official registry record

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 NCT02777528 on ClinicalTrials.gov ↗ ← All trials in Japan