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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

RecruitingNAAges 18 Years - anyAllUniversity of Tennessee Graduate School of Medici…
NCT07205068 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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)

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📋 Eligibility rules (as published)
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
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What it tests

  • Shockwave M5 IVL Catheter
  • Modified Seldinger Technique
  • Modified Seldinger Technique
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Where

1 site
University of Tennessee Medical Center
Knoxville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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