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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

ConditionAortic Stenosis
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Shockwave M5 IVL Catheter

    Device

    The Shockwave M5 IVL Catheter is a balloon catheter designed to modify calcified arterial plaque using intravascular lithotripsy prior to vascular access

  • Modified Seldinger Technique

    Procedure/Surgery

    Standard of care for femoral access in patients with calcified femoral arteries

  • Modified Seldinger Technique

    Procedure/Surgery

    Standard femoral artery access using the modified Seldinger technique without any prior vessel preparation or plaque modification.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Shockwave model (M5) Intravascular Lithotripsy (IVL)Experimental treatment 2 interventions
Group B: Standard femoral accessActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Evaluate for contrast extravasation post closure of femoral artery at the end of the procedure

Time frame
Immediately post-procedure

Secondary outcomes

1

Determine need for Vascular surgery consultation

Time frame
During hospital stay (Day 0-3)
2

If vascular complication, was PTA, stenting, or open surgery used

Time frame
During hospital stay (Day 0-3)
3

Number of perclose devices used to close the femoral artery access site

Time frame
During procedure (Day 0)
4

Determine presence of other vascular complications I.e. bleeding, hematoma, emboli etc

Time frame
Within 3 days post-procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Tennessee Graduate School of Medicine

Lead sponsor

Shockwave Medical, Inc.

Collaborator

Source ClinicalTrials.gov
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