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

Completed

Conditions studied: Aortic Dissection

In brief

Assess the feasibility of the treatment of DeBakey Type I/II aortic dissections with the GORE® Ascending Stent Graft

Key facts

Study ID: NCT02380716
Run by: W.L.Gore & Associates
People needed: 21
Starts: 2015-08-01
Expected to finish: 2026-04-01
Last updated by the study team: 2026-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

University of Southern California- Keck Medicine — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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