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

Yale University

Status

Enrolling

Conditions

Claudication

Femoral Arterial Calcification

Critical Limb Ischemia

Peripheral Arterial Disease

Treatments

Device: Shockwave Intravascular Lithotripsy (IVL)

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05145478

2000031113

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

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.

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