Improved Outcomes With Pre-Procedure Shockwave IVL of Common Femoral Artery Access Site Prior to Large Bore Access and Pre-Closure
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• \>18 years of age
• Patient with a diagnosis of severe aortic stenosis undergoing TAVR
• Participants must be able to read and understand study procedures
• Willing to participate and sign an ICF
• Patients with \> 90-degree arc of calcium at the large bore access site per CT documentation
Locations
United States
Tennessee
University of Tennessee Medical Center
RECRUITING
Knoxville
Time Frame
Start Date: 2025-10-04
Estimated Completion Date: 2026-11-04
Participants
Target number of participants: 100
Treatments
Experimental: Shockwave model (M5) Intravascular Lithotripsy (IVL)
Patients will be treated with the Shockwave M5 Intravascular Lithotripsy (IVL) device prior to femoral artery access using the modified Seldinger technique
Active_comparator: Standard femoral access
Patients will receive standard femoral artery access via the modified Seldinger approach without utilizing intravascular lithotripsy in heavily calcified femoral arteries
Related Therapeutic Areas
Sponsors
Collaborators: Shockwave Medical, Inc.
Leads: University of Tennessee Graduate School of Medicine