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CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions

NCT05145478 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2025-11-05

No results posted yet for this study

Summary

The primary goal of the study is to obtain effect size data on the use of Shockwave Intravascular Lithotripsy (IVL) technology in calcified common femoral lesions in patients with peripheral artery disease for a series of endpoints, including target lesion revascularization and health status, to enable future planning of comparative effectiveness research.

Conditions

  • Femoral Arterial Calcification
  • Peripheral Arterial Disease
  • Claudication
  • Critical Limb Ischemia

Interventions

DEVICE

Shockwave Intravascular Lithotripsy (IVL)

Eligible patients with atherosclerotic lesions in the femoral artery who either have claudication or critical limb ischemia will receive endovascular treatment in addition to be treated with Shockwave Intravascular Lithotripsy (IVL) technology.

Sponsors & Collaborators

  • Shockwave Medical, Inc.

    collaborator INDUSTRY

  • Brown University

    collaborator OTHER

  • Yale University

    lead OTHER

Principal Investigators

  • Carlos Mena-Hurtado, MD · Yale University

  • Kim Smolderen, PhD · Yale University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2026-06-01
Completion
2027-06-01
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 NCT05145478 on ClinicalTrials.gov