Status:
RECRUITING
Improved Outcomes With Pre-Procedure Shockwave IVL of Common Femoral Artery Access Site Prior to Large Bore Access and Pre-Closure
Lead Sponsor:
University of Tennessee Graduate School of Medicine
Collaborating Sponsors:
Shockwave Medical, Inc.
Conditions:
Aortic Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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)
Detailed Description
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...
Eligibility Criteria
Inclusion
- \>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
Exclusion
- Unable to understand study procedures
- Unwilling to give consent
- Patients with cognitive impairments that can affect their ability to give consent
- Unfavorable calcium distribution of femoral artery
Key Trial Info
Start Date :
October 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 4 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07205068
Start Date
October 4 2025
End Date
November 4 2026
Last Update
October 3 2025
Active Locations (1)
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1
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920