CompletedNot Applicable

DARTS I: Feasibility, Safety, and Performance Trial

Germany7 participantsStarted 2018-03-07

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

✓. Informed Consent obtained
✓. ≥18 years of age or ≤80 years of age (male or female)
✓. Acute DeBakey I dissection or
✓. Acute DeBakey 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
✕. Institutionalized individualized due to administrative or judicial order
✕. Individuals with a dependent relationship to the sponsor or investigator
✕. Uncontrolled systemic infection

What they're measuring

Number of participants with treatment-related mortality

Timeframe: 12 weeks

Number of participants with treatment-related neurological deficit

Timeframe: 12 weeks

Number of patients with aortic injury associated with the implantation of the device

Timeframe: 12 weeks

Aortic arch branch vessel patency

Timeframe: 12 weeks

Trial details

NCT IDNCT03397251

SponsorAscyrus Medical LLC.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-09-26

View on ClinicalTrials.gov More Acute DeBakey I Aortic Dissection trials