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.
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
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
Study population include patients with atherosclerotic lesions in the femoral artery who either have claudication or critical limb ischemia who are eligible to receive endovascular treatment in addition to be treated with Shockwave Intravascular Lithotripsy (IVL) technology.
Cohort
Prospective
Shockwave Intravascular Lithotripsy (IVL)
DeviceEligible 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.
Change in Generic Health Status
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.
Change in Generic Health Status
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
Procedural success defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB
Number of Patients Free from TLR
Freedom from clinically driven target lesion revascularization (TLR). Assessed at 30 days, 6 months and 12 months.
Number of patients with new-onset MAEs
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
Rate of Periprocedural clinical success
Periprocedural clinical success as defined by residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB or stenting.
Change in Clinical Success
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.
Change in Health Status
Health status will be measured using the disease-specific Peripheral Artery Questionnaire (PAQ). PAD-specific, multi-dimensional health status instrument with a CLI specific module. Higher scores indicate better functioning.
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