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

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

The primary objective of this study is to determine the safety and efficacy of the GORE Conformable TAG Thoracic Endoprosthesis (CTAG) for treatment of subjects with 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

Exclusion Criteria:

1. Primary treatment indication is Class 2-5 aortic dissection (intramural hematoma, limited dissection, penetrating atherosclerotic ulcer, iatrogenic dissection, traumatic dissection) 46
2. Concomitant aneurysm/disease of the ascending aorta, aortic arch, or abdominal aorta requiring repair (dissection extension into the abdominal aorta is acceptable)
3. Prior repair of DTA
4. Infected aorta
5. Subject has a systemic infection and may be at increased risk of endovascular graft infection
6. Persistent refractory shock (systolic blood pressure <90 mm Hg)
7. 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)
8. Renal failure , defined as baseline creatinine ≥ 2.5 mg/dl
9. ASA risk classification = V (Moribund patient not expected to live 24 hours with or without operation)
10. Pregnant female
11. Major surgery within 30 days of treatment (other than left subclavian artery bypass or transposition)
12. Degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome
13. Treatment in another drug or medical device study within 1 year of study enrollment
14. History of stimulant abuse, e.g., cocaine or amphetamine, within 1 year of treatment
15. Tortuous or stenotic iliac and/or femoral arteries and the inability to use a conduit for vascular access
16. Planned coverage of left carotid or celiac arteries with the CTAG device
17. The planned endovascular procedure involves alterations to the CTAG device
18. Subject has known sensitivities or allergies to the device materials