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

Inclusion Criteria

• •1. 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
• •2. Age 18 to 80 years
• •3. 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
• •4. 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
• •5. Subject is capable of complying with protocol requirements, including follow-up
• •6. Informed Consent Form is signed by subject or legal representative