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

Recruiting now · Not applicable

Conditions studied: Aortic Stenosis

In brief

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)

Key facts

Study ID

NCT07205068

Run by

University of Tennessee Graduate School of Medicine

People needed

100

Starts

2025-10-04

Expected to finish

2026-11-04

Last updated by the study team

2025-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• >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

You may not qualify if…

• 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

Where it is running

• University of Tennessee Medical Center — Knoxville, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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