University of Tennessee Graduate School of Medicine
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)
This is a prospective randomized/control trial pilot study to compare clinical outcomes of common femoral artery access in patients undergoing TAVR at the University of Tennessee Medical. Specifically, This study compares patients utilizing the Shockwave model (M5) Intravascular Lithotripsy (IVL) prior to standard arterial access using the modified Seldinger technique to those utilizing the standard femoral artery access via the modified Seldinger approach without the utilization of intravascular lithotripsy in heavily calcified femoral arteries. The secondary purposes of this study are to:…
Inclusion Criteria: 1. \>18 years of age 2. Patient with a diagnosis of severe aortic stenosis undergoing TAVR 3. Participants must be able to read and understand study procedures 4. Willing to participate and sign an ICF 5. Patients with \> 90-degree arc of calcium at the large bore access site per CT documentation Exclusion Criteria: 1. Unable to understand study procedures 2. Unwilling to give consent 3. Patients with cognitive impairments that can affect their ability to give consent 4. Unfavorable calcium distribution of femoral artery
The Shockwave M5 IVL Catheter is a balloon catheter designed to modify calcified arterial plaque using intravascular lithotripsy prior to vascular access
Standard of care for femoral access in patients with calcified femoral arteries
Standard femoral artery access using the modified Seldinger technique without any prior vessel preparation or plaque modification.
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