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The purpose of this study is to assess the feasibility of the use of the GORE® TAG® Thoracic Branch Endoprosthesis to treat aneurysms involving the proximal Descending Thoracic Aorta (DTA)
Full description
The GORE® TAG® Thoracic Endoprosthesis (TAG® Device) received premarket approval (PMA) for use in endovascular aneurysm repair of the descending thoracic aorta (DTA) on 23-Mar-2005 under P040043, and design changes that resulted in the conformable GORE® TAG® Thoracic Endoprosthesis (CTAG Device) received premarket approval for the treatment of aneurysms of the DTA on 23-Aug-2011 (P040043/S039). The TAG® Device and CTAG Device are intended to exclude an aneurysm from the blood circulation in patients diagnosed with DTA aneurysms. However, endovascular-only treatment options for patients with aneurysms approaching the aortic arch are limited as current stent graft technology would require coverage of the left subclavian artery (LSA) which may result in the need for a surgical revascularization procedure. This prompted the creation of the GORE® TAG® Thoracic Branch Endoprosthesis (previously known as Branched TAG® Device), which was evaluated in this study under IDE G130120 for Zone 2 aneurysms of the DTA.
Enrollment
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Inclusion criteria
Presence of DTA aneurysm deemed to warrant surgical repair which requires proximal graft placement in Zone 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, defined as:
Must have appropriate distal aortic landing zone, defined as:
Must have appropriate LSA landing zone, defined as:
Exclusion criteria
Concomitant aneurysm/disease of the ascending aorta, aortic arch, or 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 of treatment
Infected aorta
Dissection of the DTA
Intramural hematoma of the DTA without DTA aneurysm
Life expectancy <2 years
Myocardial infarction or stroke within 6 weeks prior to treatment
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
Significant thrombus or atheroma in the aortic arch
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 left carotid or celiac arteries
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
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
Additionally, the following exclusion criteria apply for Subjects enrolled in Stage 1:
Aberrant right subclavian or left vertebral arteries
Occluded/stenosed/hypoplastic right vertebral artery
Presence of a patent left internal mammary artery (LIMA) graft
Bilateral carotid artery disease
Known incomplete Circle of Willis
Known left vertebral artery ending in posterior inferior cerebellar artery (PICA)
Primary purpose
Allocation
Interventional model
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31 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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