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 range18 Years

SexALL

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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

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