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Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta (Zone 2) (SSB 11-02)

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ClinicalTrials.gov Identifier: NCT02777593
Recruitment Status : Recruiting
First Posted : May 19, 2016
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

May 12, 2016
May 19, 2016
July 19, 2018
August 2016
July 2019   (Final data collection date for primary outcome measure)
Composite of technical success and adverse events for Zone 2 Subjects (Aneurysm Cohort) [ Time Frame: one year ]
Composite of the following events through 12 months: device technical success 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.
Same as current
Complete list of historical versions of study NCT02777593 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta (Zone 2)
Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta
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.
Not Provided
Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Aortic Aneurysm, Thoracic
  • Aorta; Lesion
Device: GORE® TAG® Thoracic Branch Endoprosthesis
Endovascular repair with the TBE Device
  • Zone 2 Aortic aneurysm
    Zone 2 Aortic Aneurysm
    Intervention: Device: GORE® TAG® Thoracic Branch Endoprosthesis
  • Zone 2 Non-aneurysm aortic lesions
    Includes dissection, traumatic transection and other isolated lesion types
    Intervention: Device: GORE® TAG® Thoracic Branch Endoprosthesis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
285
Same as current
July 2023
July 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Nick Pirooz, MHA 623-234-5519 npriooz@wlgore.com
United States
 
 
NCT02777593
SSB 11-02 Pivotal (Zone 2)
Yes
Not Provided
Not Provided
W.L.Gore & Associates
W.L.Gore & Associates
Not Provided
Principal Investigator: Michael M Dake, MD Stanford University
Principal Investigator: Himanshu Patel, MD University of Michigan
W.L.Gore & Associates
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP