Ensayos clínicos

Inclusion Criteria:

All Subjects

• Presence of thoracic aortic pathology deemed to warrant surgical repair which requires proximal graft placement in Zone 0-2:
  • Aneurysms:
    • Fusiform aneurysm (≥ 55 mm); or
    • Fusiform aneurysm (> 2 times native aortic diameter); or
    • Saccular aneurysm (no diameter criteria).
  • Non-aneurysms
    • Intramural hematoma (no diameter criteria); or
    • Penetrating aortic ulcer (no diameter criteria); or
    • Traumatic aortic transection (no diameter criteria); or
    • Other isolated lesion with non-diseased proximal and distal landing zone, or Type B aortic dissection requiring treatment for rupture or impending rupture, malperfusion syndrome, rapid expansion, uncontrollable pain, aneurysmal dilatation or prophylactic reasons; or
    • Residual aortic dissection following surgical repair of Type A aortic dissection requiring treatment. TBE implant must be at least 14 days after the surgical repair procedure.
• 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:
  • Requires placement of the proximal extent of the Aortic Component in Zone 0-2 for exclusion of the lesion.
  • Acceptable proximal landing zone outer curvature length for the required device.
  • Landing zone inner diameters between 16-48 mm in Zone 1-2 Subjects and 24-48 mm in Zone 0 Subjects.
  • Landing zone includes either the brachiocephalic, left common carotid or left subclavian native ostium.
    • If the landing zone includes brachiocephalic it cannot be heavily calcified or heavily thrombosed;
    • If the landing zone includes either the left common carotid or left subclavian it cannot be heavily calcified, heavily thrombosed or aneurysmal.
  • Dissection Patients: Primary entry tear must be distal to the target branch vessel and proximal extent of the proximal landing zone must not be dissected.
  • For patients with prior replacement of the ascending aorta and/or aortic arch by a surgical graft, there must be at least 2 cm of landing zone proximal to the most distal anastomosis site.
• Must have appropriate target branch vessel landing zone, defined as:
  • Length of ≥ 3 cm proximal to first major branch vessel if using Aortic Component with 8 mm portal diameter; or
  • Length of ≥ 2.5 cm proximal to first major branch vessel if using Aortic Component with 12 mm portal diameter (required for Zone 0 Subjects);
  • Target branch vessel inner diameters of 6-15 mm if using Aortic Component with 8 mm portal diameter; or
  • Inner diameters of 11-18 mm if using Aortic Component with 12 mm portal diameter (required for Zone 0 Subjects);
  • Target branch vessel landing zone must be in native aorta that cannot be severely tortuous (i.e., vessel tortuosity that results in a 180 degree turn within the treated target branch vessel length), aneurysmal, dissected, heavily calcified, or heavily thrombosed.
• For patients with aneurysm/isolated lesion, must have appropriate distal aortic landing zone, defined as:
  • Outer curvature length must be ≥ 2 cm proximal to the celiac artery;
  • Aortic inner diameters between 16-48 mm (diameter should be between 16-42 mm if using distal CTAG Device extension);
  • Landing zone cannot be aneurysmal, heavily calcified, or heavily thrombosed;
  • Landing zone in native aorta or previously implanted Conformable GORE® TAG® Device.

Zone 0/1 Subjects Only

• Subject does not have a mechanical aortic valve.
• Subject is considered a high risk candidate for conventional open surgical repair at the discretion of the Investigator.

Exclusion Criteria:

All Subjects

• 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;
  • Surgery to treat any other presenting injuries in Traumatic Transection subjects only.
• 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 an active systemic infection (e.g. infection requiring treatment with parenteral anti-infective medication) that may place the patient at increased risk of endovascular infection. Patients with a chronic infection (such as HIV, Hepatitis C, etc.) that is well controlled under their current treatment regimen may be eligible.
• 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 (ml/min/1.73 m2) or currently requiring dialysis.

Zone 0/1 Subjects Only

• Patient at high risk for a neurological event; e.g., stroke.

Zone 0/1 Subjects Only: