RecruitingNot Applicable

Improved Outcomes With Pre-Procedure Shockwave IVL of Common Femoral Artery Access Site Prior to Large Bore Access and Pre-Closure

United States100 participantsStarted 2025-10-04

Plain-language summary

The primary purpose of this study is to observe reduced access site complications in patients with heavily calcified common femoral arteries requiring Transcatheter Aortic Valve Replacement (TAVR)

Who can participate

Age range

18 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

. \>18 years of age
. Patient with a diagnosis of severe aortic stenosis undergoing TAVR
. Participants must be able to read and understand study procedures
. Willing to participate and sign an ICF
. Patients with \> 90-degree arc of calcium at the large bore access site per CT documentation

Exclusion criteria

. Unable to understand study procedures
. Unwilling to give consent
. Patients with cognitive impairments that can affect their ability to give consent
. Unfavorable calcium distribution of femoral artery

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

Evaluate for contrast extravasation post closure of femoral artery at the end of the procedure

Timeframe: Immediately post-procedure

Trial details

NCT IDNCT07205068

SponsorUniversity of Tennessee Graduate School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-04

View on ClinicalTrials.gov More Aortic Stenosis trials