Active — Not RecruitingNot Applicable

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

United States21 participantsStarted 2015-08

Plain-language summary

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

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. DeBakey Type I/II aortic dissection compatible with the treatment requirements of GORE® Ascending Stent Graft, including:
✓. 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

✕. 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

All Cause Mortality at 30 Days Post-procedure

Timeframe: 30 days post-procedure

NCT IDNCT02380716

SponsorW.L.Gore & Associates

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-02-26

Results submitted2022-12-08