RecruitingNot Applicable

Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR

United States50 participantsStarted 2023-03-30

Plain-language summary

To assess the efficacy and safety of Intravascular Lithotripsy (IVL) in subjects undergoing transfemoral TAVR in patients with severe iliac disease, prohibitive for transfemoral TAVR in patients with severe symptomatic aortic stenosis, otherwise considered for alternative access TAVR. (e.g. trans-carotid)

Who can participate

Age range18 Years – 90 Years

SexALL

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Inclusion criteria

✓. Age 18 to 90 years of age, inclusive, at the time of signing the informed consent
✓. Iliofemoral disease warrants treatment, per routine guidelines (greater than 50% stenosis and heavy calcification of the iliac's).
✓. Severe symptomatic aortic stenosis and undergoing a planned TAVR procedure
✓. Prohibitive iliofemoral disease, as determined by the diagnostic CT abdomen and pelvis.
✓. Subjects can provide written, informed consent.

Exclusion criteria

✕. Subject is participating in another research study involving an investigational agent that has not reached the primary endpoint.
✕. Subject who has contraindications to IVL
✕. Subject who has contraindications or is not eligible for TAVR

What they're measuring

Acute technical success per the DISRUPT PAD definition at the time of intervention

Timeframe: At time of IVL procedure

Success rate of transfemoral delivery of a TAVR system post IVL within 30 days of treatment

Timeframe: At the time of TAVR procedure

Trial details

NCT IDNCT05862558

SponsorBaylor Research Institute

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-06-01

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