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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

NCT07205068 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-10-03

No results posted yet for this study

Summary

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

  • Aortic Stenosis

Interventions

DEVICE

Shockwave M5 IVL Catheter

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

PROCEDURE

Modified Seldinger Technique

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

PROCEDURE

Modified Seldinger Technique

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

Sponsors & Collaborators

  • Shockwave Medical, Inc.

    collaborator INDUSTRY

  • University of Tennessee Graduate School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-04
Primary Completion
2026-11-04
Completion
2026-11-04
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07205068 on ClinicalTrials.gov