ARISE: Evaluation of the GORE® Ascending Stent Graft in the Treatment of DeBakey Type I/II Aortic Dissection

This study is a prospective, multicenter, non-randomized single-arm study to assess the feasibility of the treatment of DeBakey Type I/II aortic dissections with the GORE® Ascending Stent Graft.

Inclusion criteria

• 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
• Able to undergo CT scan per protocol requirements to perform required case planning prior to endovascular procedure
• High surgical risk, as determined by the implanting physician
• Adequate vascular access via transfemoral or retroperitoneal approach
• An Informed Consent Form signed by Subject or legally authorized representative
• Able to comply with protocol requirements including follow-up

Exclusion criteria

• Planned aortic valve repair or replacement or coronary artery intervention within 30 days
• Presence of mechanical heart valve in the aortic position
• Primary entry tear location in the aortic arch or descending thoracic aorta with retrograde flow into the ascending aorta
• Aortic insufficiency grade 3+ or 4+
• Known irreversible neurological injury
• Known degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
• Participation in another drug or medical device study within 1 year of study enrollment
• Known history of drug abuse
• Pregnant female at time of informed consent signature
• Body habitus or other medical condition which prevents adequate visualization of the aorta
• Systemic infection that could increase the risk of endovascular graft infection
• Previous thoracic aortic surgery
• Life expectancy <12 months due to associated non-cardiac co-morbid conditions
• Subject has known sensitivities or allergies to the device materials
• Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
• Patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment