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Trial record 2 of 2 for:    gore tbe

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) (SSB 11-02)

This study is currently recruiting participants.
Verified September 2017 by W.L.Gore & Associates
Sponsor:
ClinicalTrials.gov Identifier:
NCT02777528
First Posted: May 19, 2016
Last Update Posted: October 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
W.L.Gore & Associates
  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.

Condition Intervention
Aortic Aneurysm, Thoracic Aorta, Lesion Device: GORE® TAG® Thoracic Branch Endoprosthesis Procedure: Revascularization Procedure

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta

Resource links provided by NLM:


Further study details as provided by W.L.Gore & Associates:

Primary Outcome Measures:
  • Composite of Initiation of Index Procedure, Device Technical Success and Adverse Events for Zone 0/1 Subjects (Aneurysm Cohort) [ Time Frame: 1 month ]
    Composite of the following events through one month: 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.


Estimated Enrollment: 150
Study Start Date: August 2016
Estimated Study Completion Date: July 2024
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Zone 0/1 Aortic aneurysm
Zone 0/1 Aortic aneurysm
Device: GORE® TAG® Thoracic Branch Endoprosthesis
Endovascular repair with the TBE Device
Procedure: Revascularization Procedure
Revascularization procedure of the great vessel
Zone 0/1 Non-aneurysm aortic lesions
Includes dissection and other isolated lesion types
Device: GORE® TAG® Thoracic Branch Endoprosthesis
Endovascular repair with the TBE Device
Procedure: Revascularization Procedure
Revascularization procedure of the great vessel

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02777528


Contacts
Contact: Nick Pirooz, MHA 623-234-5519 npirooz@wlgore.com

  Show 38 Study Locations
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
Principal Investigator: Michael Dake, MD Stanford University
Principal Investigator: Himanshu Patel, MD University of Michigan
  More Information

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT02777528     History of Changes
Other Study ID Numbers: SSB 11-02 Pivotal (Zone 0/1)
First Submitted: May 12, 2016
First Posted: May 19, 2016
Last Update Posted: October 2, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases