Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by William Quinones-Baldrich (ucla)

Description

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.

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

Keywords

Aortic Aneurysm, Thoracic Aorta, Lesion Aneurysm Aortic Aneurysm GORE® TAG® Thoracic Branch Endoprosthesis Revascularization Procedure Zone 0/1 Aortic aneurysm Zone 0/1 Non-aneurysm aortic lesions

Eligibility

You can join if…

Open to people ages 18 years and up

  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)

You CAN'T join if...

  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

Locations

  • University of California - Los Angeles accepting new patients
    Los Angeles California 90095 United States
  • Cedar-Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States
  • Keck Medical Center of USC accepting new patients
    Los Angeles California 90033 United States
  • Leland Stanford Junior University accepting new patients
    Stanford California 94305-5407 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
W.L.Gore & Associates
ID
NCT02777528
Study Type
Interventional
Participants
Expecting 150 study participants
Last Updated