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

Recruiting

Conditions: Critical Limb Ischemia
Peripheral Arterial Disease
Femoral Arterial Calcification
Claudication

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.

Recruitment & Eligibility

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.
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.

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

Arm && Interventions

Group	Intervention	Description
Shockwave Intravascular Lithotripsy (IVL)	Shockwave Intravascular Lithotripsy (IVL)	Patients with calcified common-femoral artery disease, who are eligible to receive IVL per the FDA indications.

Primary Outcome Measures

Name	Time	Method
Change in Generic Health Status	Baseline 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 Success	Immediately post procedure	Procedural success defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB

Secondary Outcome Measures

Name	Time	Method
Number of patients with new-onset MAEs	Up to 12 months	The composite of new-onset Major Adverse Events (MAEs) is comprised of: * Need for emergency surgical revascularization of target limb, including CFA endarterectomy * Unplanned target limb major amputation (above the ankle) * Symptomatic thrombus or distal emboli that require surgical, mechanical, or pharmacologic means to improve flow and extend hospitalization * Perforations that require an intervention, including bail-out stenting
Number of Patients Free from TLR	Up to 12 months	Freedom from clinically driven target lesion revascularization (TLR). Assessed at 30 days, 6 months and 12 months.
Rate of Periprocedural clinical success	During admission, before discharge up to 48 hours	Periprocedural clinical success as defined by residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB or stenting.
Change in Clinical Success	Baseline, 6 months and 12 months	Rutherford Category. Classification of PAD into acute and chronic limb ischemia associated by clinical symptoms. Evaluates patient's chronic limb pain and claudication by ABI/TBI. The category scale is from 0-6. The clinical interpretation of the scale is that a higher category indicates a worse condition.

Locations (1): Yale New Haven Health
🇺🇸
New Haven, Connecticut, United States