This study is looking at ways to reduce complications when placing a large catheter (tube) into a blood vessel in your leg for a procedure called Transcatheter Aortic Valve Replacement (TAVR). TAVR is a procedure to replace a narrowed heart valve (aortic stenosis). Researchers are comparing two approaches for patients with calcium buildup in their leg artery. One group will receive treatment with the Shockwave M5 IVL Catheter, which uses sound waves to break up calcium before the catheter is inserted. The other group will receive the standard approach without this extra step. The main goal is to see if using the Shockwave M5 IVL Catheter reduces bleeding or leakage from the access site after the procedure. This study is currently recruiting 100 participants and is taking place at the University of Tennessee Medical.

Study design

This is a pilot study comparing two groups of 100 participants, one receiving the Shockwave M5 IVL Catheter and the other receiving standard care. Participants will be randomly assigned to one of these groups.

What's involved

You would undergo a TAVR procedure, with either the Shockwave M5 IVL Catheter or standard access. The study will evaluate your condition immediately after the procedure.

Compensation

Not stated in the trial record.

Follow-up

The primary outcome, contrast extravasation (leakage), is measured immediately after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.