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

NCT ID: NCT05145478

Last Updated: 2025-11-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2027-06-01

Brief 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.

Detailed Description

The primary objective of this study is to evaluate the generic health status outcomes and efficacy and safety outcomes following use of the Shockwave Intravascular Lithotripsy (IVL) technology in calcified common femoral lesions in patients with PAD seen in routine clinical practice.

The main testable hypothesis is that the use of IVL is associated with a health status improvement that is equal or higher than the threshold of a minimally clinically important difference on the EQ5D. Preliminarily data will be derived for the primary endpoint target lesion revascularization to enable future planning of larger comparative effectiveness research.

Secondary objectives of the study are to document procedural success following the use of IVL in common femoral lesions, disease stage change, as well as disease-specific health status in the real-world.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Shockwave Intravascular Lithotripsy (IVL)

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

Shockwave Intravascular Lithotripsy (IVL)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion 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.
• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shockwave Medical, Inc.

INDUSTRY

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlos Mena-Hurtado, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Kim Smolderen, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale New Haven Health

New Haven, Connecticut, United States

Site Status: RECRUITING

The Miriam Hospital

Providence, Rhode Island, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Kim Smolderen, PhD

Role: CONTACT

kim.smolderen@yale.edu

203-737-7673

Facility Contacts

Carlos Mena-Hurtado, MD

Role: primary

Peter A Soukas, MD

Role: primary

psoukas@brownhealth.org

401-793-4105

Other Identifiers

2000031113

Identifier Type: -

Identifier Source: org_study_id