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)

  • STATUS
    Recruiting
  • End date
    Dec 16, 2026
  • participants needed
    315
  • sponsor
    W.L.Gore & Associates
Updated on 16 October 2021

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.

Details
Condition Thoracic aortic aneurysm, Aorta; Lesion
Treatment GORE® TAG® Thoracic Branch Endoprosthesis
Clinical Study IdentifierNCT02777593
SponsorW.L.Gore & Associates
Last Modified on16 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Presence of thoracic aortic pathology deemed to warrant surgical repair which requires proximal graft placement in Zone 0-2
Age 18 years at time of informed consent signature
Subject is capable of complying with protocol requirements, including follow-up
Informed Consent Form (ICF) is signed by Subject or legal representative
Must have appropriate proximal aortic landing zone
Must have appropriate target branch vessel landing zone
For patients with aneurysm/isolated lesion, must have appropriate distal aortic landing zone

Exclusion Criteria

Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair
Previous endovascular repair of the ascending aorta
Previous endovascular repair of the DTA with a non-Gore device
Surgery within 30 days prior to enrollment, with the exception of surgery for Ascending Aortic Dissection and/or placement of vascular conduit for access
Infected aorta
Life expectancy <2 years
Myocardial infarction within 6 weeks prior to treatment
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
Patient has a systemic infection and may be at increased risk of endovascular graft infection
Pregnant female at time of informed consent signature
Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
Participation in another drug or medical device study within one year of study enrollment
Known history of drug abuse within one year of treatment
Presence of protruding and/or irregular thrombus and/or atheroma in the aortic arch or ascending aorta
Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access
Planned coverage of celiac artery
Patient has known sensitivities or allergies to the device materials
Patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment
Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
Patient with a history of a hypercoagulability disorder and/or hypercoagulability state
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
Mycotic aneurysm
Persistent refractory shock (systolic blood pressure <90 mm Hg)
Patient has body habitus or other medical condition which prevents adequate visualization of the aorta
Renal failure defined as patients with an estimated Glomerular Filtration Rate (eGFR) <30 or currently requiring dialysis
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