Improved Outcomes With Pre-Procedure Shockwave IVL of Common Femoral Artery Access Site Prior to Large Bore Access and Pre-Closure

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Tennessee Graduate School of Medicine

About this trial

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 criteria

Qualifiers

>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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators