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Shockwave Lithotripsy for Calcified Leg Artery Blockages in Peripheral Artery Disease

Observes how shockwave lithotripsy works in people with peripheral artery disease and calcified femoral arteries.

Key facts

Who runs it
Yale University
Where
New Haven and Providence, United StatesSee the 2 sites
Trial code
Registry title
CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions
Status
Recruiting
People taking part
50 people, planned
Started
1 Dec 2021
Expected to end
1 Jun 2027
Type of study
Observational
Treatments tested
  • Shockwave Intravascular Lithotripsy (IVL)
Record updated
14 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with peripheral artery disease and a hardened (calcified) narrowing in the common femoral artery in the groin. They must be scheduled for treatment with Shockwave Intravascular Lithotripsy (IVL).

Age
18 Years and older
Sex
All
Disease stage
Leg pain on walking (claudication) or critical limb ischemia, Rutherford Clinical Category 2, 3, 4, 5, or 6. The narrowing is in a native, de novo common femoral artery, is ≥70% narrowed, is ≤50mm long, sits in a vessel 4.0mm to 7.0mm wide, and has at least moderate calcification. Fully blocked arteries (chronic total occlusion) of ≤50mm can join.
Earlier treatment
People cannot join if they had a prior CFA endarterectomy (surgery to clean out the common femoral artery). People must be fit enough to have angiography and treatment from inside the artery.

Main reasons for not taking part

  • Pregnancy or breastfeeding
  • Expected survival less than 12 months
  • Prior CFA endarterectomy
  • Cognitive impairment in medical records, or not speaking English or Spanish
  • Currently a prisoner, or in another study that would interfere

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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; Angiographic Inclusion Criteria
  • 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

Who cannot take part

  • 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
  • Prior history of CFA endarterectomy
  • Cognitive impairment as documented in medical records
  • Subject is already enrolled in other investigational (interventional) studies that would interfere with study endpoints
  • Not speaking English or Spanish
  • Currently a prisoner
  • Pregnancy or nursing
  • Estimated survival less than 12 months at the time of screening

Where in United States

  • Yale New Haven HealthNew Haven, United StatesContact: Carlos Mena-Hurtado, MDTaking people
  • The Miriam HospitalProvidence, United StatesContact: Peter A Soukas, MDNot yet recruiting

About the trial

What the trial wants to find out

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.

The group in the trial

  • Shockwave Intravascular Lithotripsy (IVL)

    Patients with calcified common-femoral artery disease, who are eligible to receive IVL per the FDA indications.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
CTA_IIT_CRUSH PAD: Real-world Outcomes Following Use of the Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions
Plain-language title
Shockwave Lithotripsy for Calcified Leg Artery Blockages in Peripheral Artery DiseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
14 August 2026