Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Acute Complicated Type B Aortic Dissection

Inclusion criteria

• Presence of acute complicated type B aortic dissection:

• Dissection is acute Time from symptom onset to dissection diagnosis ≤14 days
• Dissection is complicated

Subject must present with at least one of the following:

• Rupture in the setting of an aortic dissection defined as hemorrhage outside of the aortic boundaries -which is noted by CT scan (hemorrhage must be differentiated from reactive effusions by the investigator, or if equivocal, having elevated Hounsefield units as determined by the radiologist).
• Clinical evidence of malperfusion, in the setting of an aortic dissection, defined as:

• Clinical or radiographic evidence of visceral hypoperfusion.
• Clinical or radiographic evidence of renal hypoperfusion.
• Clinical or radiographic evidence of lower extremity hypoperfusion.
• Clinical or radiographic evidence of spinal cord hypoperfusion.

• Dissection is type B Entire dissection is distal to the left subclavian artery
• Primary Treatment Indication is Class 1 Aortic Dissection 46 Classical aortic dissection with intimal flap between true and false lumen with double barrel flow in thoracic aorta
• Subjects with multiple entry tears are allowed to be enrolled in the study
• Age 18 to 80 years
• Primary treatment is endovascular treatment with the CTAG device. Adjunctive treatments may include left subclavian artery revascularization, percutaneous fenestration, aortic stenting, peripheral vessel stenting, surgical fenestration, and/or peripheral artery bypass
• Proximal landing zone characteristics include:

• Proximal extent of intended proximal landing zone cannot be dissected
• Length ≥ 2.0 cm proximal to the primary entry tear
• Trans-aortic diameter at proximal extent of intended landing zone between 16-42 mm (diameter assessed by flow lumen and thrombus, if present; calcium excluded)
• Cannot be aneurysmal, heavily calcified, or have excessive intraluminal thrombus
• Must be native aorta
• May include left subclavian artery, if necessary
• Subject is capable of complying with protocol requirements, including follow-up
• Informed Consent Form is signed by subject or legal representative

Exclusion criteria

• Primary treatment indication is Class 2-5 aortic dissection (intramural hematoma, limited dissection, penetrating atherosclerotic ulcer, iatrogenic dissection, traumatic dissection) 46
• Concomitant aneurysm/disease of the ascending aorta, aortic arch, or abdominal aorta requiring repair (dissection extension into the abdominal aorta is acceptable)
• Prior repair of DTA
• Infected aorta
• Subject has a systemic infection and may be at increased risk of endovascular graft infection
• Persistent refractory shock (systolic blood pressure <90 mm Hg)
• Bowel necrosis (Bowel necrosis will be characterized by direct observation with surgical exploration, or elevated serum lactate level and CT findings of portal venous gas, free intra-abdominal gas, pneumatosis intramural gas, and poor mucosal enhancement of thickened bowel wall)
• Renal failure , defined as baseline creatinine ≥ 2.5 mg/dl
• ASA risk classification = V (Moribund patient not expected to live 24 hours with or without operation)
• Pregnant female
• Major surgery within 30 days of treatment (other than left subclavian artery bypass or transposition)
• Degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome
• Treatment in another drug or medical device study within 1 year of study enrollment
• History of stimulant abuse, e.g., cocaine or amphetamine, within 1 year of treatment
• Tortuous or stenotic iliac and/or femoral arteries and the inability to use a conduit for vascular access
• Planned coverage of left carotid or celiac arteries with the CTAG device
• The planned endovascular procedure involves alterations to the CTAG device
• Subject has known sensitivities or allergies to the device materials