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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
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-10-04
Completion Date
2026-11-04
Last Updated
2025-10-03
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
University of Tennessee Medical Center
Knoxville, Tennessee, United States