CompletedNot Applicable

DARTS I Feasibility Study

Canada40 participantsStarted 2017-03-05

Plain-language summary

The objective of this study is to investigate the feasibility and clinical benefits of the AMDS to treat patients with acute DeBakey type I dissections and/or intramural hematomas (IMH) involving the ascending aorta and aortic arch through open surgical repair.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Acute DeBakey type I dissection or
✓. Acute DeBakey type I intramural hematoma (IMH)

Exclusion criteria

✕. Less than 18 years of age or over 80 years of age
✕. Life expectancy less than 2 years
✕. Pregnant or breastfeeding or planning on becoming pregnant within 60 months
✕. Unwilling to comply with the follow-up schedule
✕. Refusal to give informed consent
✕. Uncontrolled systemic infection
✕. Uncontrollable anaphylaxis to iodinated contrast
✕. Known allergy(ies) to Nitinol and/or PTFE

What they're measuring

Number of participants with device-related mortality

Timeframe: Early (within 30 days)

Number of participants with device-related mortality

Timeframe: Intermediate (3 months)

Number of participants with device-related mortality

Timeframe: Late (6 months)

Number of participants with neurological complications (TIA, stroke)

Timeframe: Early (within 30 days)

Number of participants with neurological complications (TIA, stroke)

Timeframe: Intermediate (3 months)

Number of participants with neurological complications (TIA, stroke)

Timeframe: Late (6 months)

Trial details

NCT IDNCT03035643

SponsorAscyrus Medical LLC.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-08-21

View on ClinicalTrials.gov More Aortic Dissection trials