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CRUSH PAD: Shockwave Intravascular Lithotripsy for Femoral Artery Calcification

This study is looking at how well Shockwave Intravascular Lithotripsy (IVL) works for people with hardened (calcified) arteries in their legs, specifically in the common femoral artery. This condition is often part of peripheral arterial disease (PAD), which can cause leg pain when walking (claudication) or more severe problems like critical limb ischemia. The study will observe 50 patients who are already scheduled to receive IVL treatment. Researchers will measure changes in your general health status at 30 days and 6 months, and how successful the procedure is right after it's done. The goal is to see if IVL improves health and to help plan future research.

Study design
This is an observational study, meaning researchers will watch what happens to 50 patients who are already receiving Shockwave Intravascular Lithotripsy (IVL) as part of their routine care.
What's involved
You would receive endovascular treatment, including Shockwave Intravascular Lithotripsy (IVL) technology, as part of your scheduled medical care. Your health status would be measured at the start, 30 days, and 6 months after the procedure.
Compensation
Not stated in the trial record.
Follow-up
Your health status will be followed for 6 months after the procedure.

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NCT05145478

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

Recruiting
Not specifiedAges 18+Observational
Yale University
~50 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Shockwave Intravascular Lithotripsy (IVL)

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Generic Health Status
Measured over Baseline and 30 days
+2 more outcomes measured

Conditions

Femoral Arterial Calcification
Peripheral Arterial Disease
Claudication
Critical Limb Ischemia

Explore related trials

Chronic Limb-Threatening IschemiaClaudicationPeripheral Artery Disease

Where it's being run

2 sites across 2 states
Connecticut1
Rhode Island1

Study leadership

  • Carlos Mena-Hurtado, MD · PRINCIPAL_INVESTIGATOR · Yale University
  • Kim Smolderen, PhD · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Kim Smolderen, PhD
[email protected]
203-737-7673
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Subjects presenting with claudication or CLI by Rutherford Clinical Category 2, 3, 4, 5, or 6 of the target limbs
Subject is a suitable candidate for angiography and endovascular intervention per the latest clinical guidelines
Patient is scheduled to undergo treatment with Shockwave Intravascular Lithotripsy (IVL) technology followed by standard of care treatment with DCB, BMS, DES at the physician's discretion.
Target lesion that is located in a native, de novo common femoral artery
Target lesion reference vessel diameter is between 4.0mm and 7.0mm by visual estimate.
Target lesion is ≥70% stenosis by investigator via visual estimate.
Target lesion length is ≤50mm for lesions 70-99% stenosed. Target lesion can be all or part of the 50mm treated zone.
Chronic total occlusion, lesion length is ≤50mm of the total ≤50 mm target lesion.
Calcification is at least moderate defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending \> 50% the length of the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is \<50mm in length.

Exclusion

Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Shockwave Medical Peripheral Lithoplasty® System as per Instructions for Use (IFU) or investigator's opinion.
Subject is already enrolled in other investigational (interventional) studies that would interfere with study endpoints.
Cognitive impairment as documented in medical records
Not speaking English or Spanish
Currently a prisoner
Pregnancy or nursing
Estimated survival less than 12 months at the time of screening
Prior history of CFA endarterectomy

What this trial measures

  • Change in Generic Health StatusBaseline and 30 days

    Generic Health Status will be measured using the EQ5D health status assessment. Descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each of which has five severity levels that are described by statements appropriate to that dimension. Higher scores indicate more severe or frequent problems.

  • Change in Generic Health StatusBaseline and 6 months

    Generic Health Status will be measured using the EQ5D health status assessment. Descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each of which has five severity levels that are described by statements appropriate to that dimension. Higher scores indicate more severe or frequent problems.

  • Rate of Procedural SuccessImmediately post procedure

    Procedural success defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB