Actively Recruiting
Improved Outcomes With Pre-Procedure Shockwave IVL of Common Femoral Artery Access Site Prior to Large Bore Access and Pre-Closure
Led by University of Tennessee Graduate School of Medicine · Updated on 2025-10-03
100
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
Sponsors
U
University of Tennessee Graduate School of Medicine
Lead Sponsor
S
Shockwave Medical, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Improved Outcomes With Pre-Procedure Shockwave IVL of Common Femoral Artery Access Site Prior to Large Bore Access and Pre-Closure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be over 18 years old
- Have a diagnosis of severe aortic stenosis and be scheduled for TAVR
- Be able to read and understand the study procedures
- Be willing to participate and sign an informed consent form
- Have more than a 90-degree arc of calcium at the large bore access site shown by CT scan
You will not qualify if you...
- Unable to understand study procedures
- Unwilling to give consent
- Have cognitive impairments affecting consent ability
- Have an unfavorable calcium distribution in the femoral artery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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