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

Part of paid clinical trials in Knoxville, Tennessee.

Sponsor
University of Tennessee Graduate School of Medicine
Study ID
NCT07205068
Status
Recruiting
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Conditions

  • Aortic Stenosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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
    Standard of care for femoral access in patients with calcified femoral arteries
  • Modified Seldinger Technique — PROCEDURE
    Standard femoral artery access using the modified Seldinger technique without any prior vessel preparation or plaque modification.

Study Details

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)

Key Dates

Start date
Oct 4, 2025
Status verified
Aug 2025
Primary completion
Nov 4, 2026
Completion
Nov 4, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Shockwave model (M5) Intravascular Lithotripsy (IVL)
    Patients will be treated with the Shockwave M5 Intravascular Lithotripsy (IVL) device prior to femoral artery access using the modified Seldinger technique
  • Active Comparator: Standard femoral access
    Patients will receive standard femoral artery access via the modified Seldinger approach without utilizing intravascular lithotripsy in heavily calcified femoral arteries

Primary Outcome Measure

Evaluate for contrast extravasation post closure of femoral artery at the end of the procedure [ Time Frame: Immediately post-procedure ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Tennessee Medical CenterKnoxvilleTennessee37920
Savannah Allen, MPH Study Coordinator
[email protected]
+1865-305-9522
Raj Baljepally, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Tennessee Medical Center· Knoxville, TN

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