RecruitingNot ApplicableNCT07205068

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

Sponsor

University of Tennessee Graduate School of Medicine

Enrollment

100 participants

Start Date

Oct 4, 2025

Study Type

INTERVENTIONAL

Conditions

Aortic Stenosis

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)

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Modified Seldinger Technique, a procedure called Modified Seldinger Technique, and others for people with aortic stenosis. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

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 M5 IVL Catheter

The Shockwave M5 IVL Catheter is a balloon catheter designed to modify calcified arterial plaque using intravascular lithotripsy prior to vascular access

PROCEDUREModified Seldinger Technique

Standard of care for femoral access in patients with calcified femoral arteries

PROCEDUREModified Seldinger Technique

Standard femoral artery access using the modified Seldinger technique without any prior vessel preparation or plaque modification.

Locations(1)

University of Tennessee Medical Center

Knoxville, Tennessee, United States

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NCT07205068

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