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 range

18 Years – 90 Years

Sex

ALL

See this in plain English?

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

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Iliac Disease trials