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

Description

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

Study Overview

Study Details

Study overview

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.

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

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

Condition
Femoral Arterial Calcification
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale New Haven Health, New Haven, Connecticut, United States, 06510

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * Patient has open profunda femoris artery for the target leg, defined as no stenosis \>50%.
  • * 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Yale University,

Carlos Mena-Hurtado, MD, PRINCIPAL_INVESTIGATOR, Yale University

Kim Smolderen, PhD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

2026-06-01