RecruitingNCT05862558

Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR

Sponsor

Baylor Research Institute

Enrollment

50 participants

Start Date

Mar 30, 2023

Study Type

OBSERVATIONAL

Conditions

Aortic Valve Stenosis Iliac Disease

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)

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Shockwave Balloon for people with aortic valve stenosis and iliac disease. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 90 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEShockwave Balloon

Intravascular lithotripsy (IVL) performed with the Shockwave balloon (Shockwave Medical Inc) enables treatment of calcified stenosis of the peripheral arteries by using sonic pressure waves to selectively disrupt superficial and deep calcium without impacting healthy tissue