New stent graft offers hope for aortic tear patients

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. DeBakey Type I/II aortic dissection compatible with the treatment requirements of GORE® Ascending Stent Graft, including: * Primary entry tear must be in the ascending aorta and ≥2cm distal to the most distal coronary artery ostia * Ascending aorta compatible with the GORE® Ascending Stent Graft including landing zone true lumen diameter between 24mm - 42mm and total aortic landing zone diameter ≤ 45 mm 2. Able to undergo CT scan per protocol requirements to perform required case planning prior to endovascular procedure 3. High surgical risk, as determined by the implanting physician 4. Adequate vascular access via transfemoral or retroperitoneal approach 5. An Informed Consent Form signed by Subject or legally authorized representative 6. Able to comply with protocol requirements including follow-up Exclusion Criteria: 1. Planned aortic valve repair or replacement or coronary artery intervention within 30 days 2. Presence of mechanical heart valve in the aortic position 3. Primary entry tear location in the aortic arch or descending thoracic aorta with retrograde flow into the ascending aorta 4. Aortic insufficiency grade 3+ or 4+ 5. Known irreversible neurological injury 6. Known degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome 7. Participation in another drug or medical device study within 1 year of study enrollment 8. Known history of drug abuse 9. Pregnant female at time of informed consent signature 10. Body habitus or other medical condition which prevents adequate visualization of the aorta 11. Systemic infection that could increase the risk of endovascular graft infection 12. Previous thoracic aortic surgery 13. Life expectancy \<12 months due to associated non-cardiac co-morbid conditions 14. Subject has known sensitivities or allergies to the device materials 15. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin 16. Patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment