Trial Search Results

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)

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

W.L.Gore & Associates

Stanford Investigator(s):


  • Device: GORE® TAG® Thoracic Branch Endoprosthesis
  • Procedure: Revascularization Procedure




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

   9. Patient has a systemic infection and may be at increased risk of endovascular graft

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

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

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting