Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 2

A vizsgálat adatai

Ki végzi

W.L.Gore & Associates

Azonosító

NCT02777593

A regiszteradat frissítve

2026. szeptember 10.

Eredeti leírás

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, requiring Zone 2 proximal implantation of the device.A teljes eredeti leírásKevesebb

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

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, requiring Zone 2 proximal implantation of the device.

Bevonási feltételek: 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.

Kizáró feltételek: 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; 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; Participation in another drug or medical device study within one year of study enrollment; Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin; Infected aorta; Patient has a systemic infection and may be at increased risk of endovascular graft infection; Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome; Known history of drug abuse within one year of treatment; 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; Patient with a history of a hypercoagulability disorder and/or hypercoagulability state; 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; Life expectancy <2 years; Pregnant female at time of informed consent signature; 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; 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).

ClinicalTrials.gov NCT02777593