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

NARecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

October 4, 2025

Primary Completion Date

November 4, 2026

Study Completion Date

November 4, 2026

Conditions
Aortic Stenosis
Interventions
DEVICE

Shockwave 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

PROCEDURE

Modified Seldinger Technique

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

PROCEDURE

Modified Seldinger Technique

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

Trial Locations (1)

37920

RECRUITING

University of Tennessee Medical Center, Knoxville

All Listed Sponsors
collaborator

Shockwave Medical, Inc.

INDUSTRY

lead

University of Tennessee Graduate School of Medicine

OTHER

NCT07205068 - Improved Outcomes With Pre-Procedure Shockwave IVL of Common Femoral Artery Access Site Prior to Large Bore Access and Pre-Closure | Biotech Hunter | Biotech Hunter