100
Participants
Start Date
October 4, 2025
Primary Completion Date
November 4, 2026
Study Completion Date
November 4, 2026
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
Modified Seldinger Technique
Standard of care for femoral access in patients with calcified femoral arteries
Modified Seldinger Technique
Standard femoral artery access using the modified Seldinger technique without any prior vessel preparation or plaque modification.
RECRUITING
University of Tennessee Medical Center, Knoxville
Shockwave Medical, Inc.
INDUSTRY
University of Tennessee Graduate School of Medicine
OTHER