Clinical Trial Details

NCT ID: NCT02777593
Date Last Changed: September 29, 2017

Overview

Research Study Summary

A clinical study for patients with Aortic Aneurysm, Thoracic or Aorta; Lesion

Research Study Title

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

Purpose

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.

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Recruitment Details

Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
W.L.Gore & Associates
Duration
35 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

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.

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

Site Locations (38)

Country State City Zip Facility and Contact
United States Alabama Birmingham 35294 University of Alabama at Birmingham

Adam Beck, MD
Principal Investigator
United States Arizona Phoenix 85006 Arizona Heart Institute

Venkatesh Ramaiah, MD
Principal Investigator
United States California Los Angeles 90033 Keck Medical Center of USC

Fernando Fleischman, MD
Principal Investigator

Fred Weaver, MD
Principal Investigator
United States California Los Angeles 90095 University of California - Los Angeles

William Quinones-Baldrich, MD
Principal Investigator
United States California Stanford 94305-5407 Leland Stanford Junior University

Michael Fischbein, MD
Principal Investigator
United States Connecticut Hartford 06106 Hartford Hospital
Thomas Divinagracia, MD
United States District of Columbia Washington, D.C. 20010 MedStar Health Research Institute

Edward Woo, MD
Principal Investigator
United States Florida Gainesville 32610 University of Florida - Gainesville

Javairiah Fatima, MD
Principal Investigator
United States Florida Tampa 33606 Univeristy of South Florida

Murray Shames, MD
Principal Investigator
United States Georgia Atlanta 30322 Emory University
William Jordan, MD

Brad Leshnower, MD
Principal Investigator
United States Illinois Chicago 60611 Northwestern University

Andrew Hoel, MD
Principal Investigator
United States Indiana Indianapolis 46290 St. Vincent Medical Group, Inc.
Sina Moainie, MD
United States Kentucky Louisville 40202 University of Louisville Jewish Hospital

Kendra Grubb, MD
Principal Investigator
United States Maryland Baltimore 21201 University or Maryland Baltimore

Robert Crawford, MD
Principal Investigator
United States Massachusetts Boston 02114 Massachusetts General Hospital

Richard Cambria, MD
Principal Investigator
United States Michigan Ann Arbor 48109 University of Michigan

Himashu Patel, MD
Principal Investigator
United States Michigan Royal Oak 48073 William Beaumont Hospital
Alessandro Vivacqua, MD
United States Minnesota Rochester 55905 Mayo Clinic Rochester

Gustavo Oderich, MD
Principal Investigator
United States Missouri Saint Louis 63110 Washington University School of Medicine

Luis A Sanchez, MD
Principal Investigator
United States New Hampshire Lebanon 03766 Dartmouth-Hitchcock Medical Center
Mark Fillinger, MD
United States New Jersey Camden 08103 Cooper University Hospital

Joseph Lombardi, MD
Principal Investigator
United States North Carolina Charlotte 28203 Carolinas HealthCare Systems

Frank Arko III, MD
Principal Investigator
United States North Carolina Durham 27710 Duke University Medical Center

G. Charles Hughes, MD
Principal Investigator
United States Ohio Cleveland 44195 Cleveland Clinic
Matthew Eagleton, MD
United States Oregon Portland 97239 Oregon Health & Science University

Cherrie Abraham, MD
Principal Investigator
United States Pennsylvania Philadelphia 19104 Hospital of the University of Pennsylvania
Nimesh Desai, MD
United States Pennsylvania Pittsburgh 15232 University of Pittsburgh Medical Center

Michael Singh, MD
Principal Investigator
United States Tennessee Memphis 38120 Cardiovascular Surgery Clinic
H. Edward Garrett, MD
United States Tennessee Nashville 37232 Vanderbilt University Medical Center

Thomas Naslund, MD
Principal Investigator
United States Texas Austin 78756 Cardiothoracic and Vascular Surgeons

Mark Felger, MD
Principal Investigator
United States Texas Houston 77030 Baylor College of Medicine - Houston

Joseph Coselli, MD
Principal Investigator
United States Texas Houston 77030 Houston Methodist Hospital
Jean Bismuth, MD
United States Texas Houston 77030 Memorial Hermann
Ali Azizzadeh, MD
United States Texas Plano 75093 Heart Hospital at Baylor Plano

William Brinkman, MD
Principal Investigator
United States Virginia Charlottesville 22908 University of Virginia

Gilbert Upchurch, MD
Principal Investigator
United States Virginia Norfolk 23507 Sentara Medical Group

Jean Panneton, MD
Principal Investigator
United States Washington Seattle 98195 University of Washington

Matthew Sweet, MD
Principal Investigator
United States Wisconsin Madison 53792 University of Wisconsin System
Charles Acher, MD

Contact

Nick Pirooz, MHA
623-234-5519
E-mail:

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