Mini S Feasibility Study With Shockwave Medical Mini S Peripheral IVL System

Study Overview
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Brief Summary
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Prospective, multi-center, single-arm feasibility study to assess the safety and performance of the Shockwave Medical Mini S Peripheral IVL System for the treatment of heavily calcified, stenotic peripheral arteries.

Official Title
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Prospective, Multi-center, Single-arm Feasibility Study of the Shockwave Medical Mini S Peripheral Intravascular Lithotripsy (IVL) System

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: Shockwave Medical Mini S Peripheral IVL Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -General Inclusion Criteria Age of subject is ≥ 18 years. Subject is able and willing to comply with all assessments in the study. Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and has signed the approved consent form. Estimated life expectancy > 1 year. Rutherford Clinical Category 2, 3, 4 or 5 of the target limb(s). Angiographic Inclusion Criteria One or two target lesion(s) located in a native de novo superficial femoral, popliteal or infrapopliteal artery (above the ankle joint), in one or both limbs. Target lesion reference vessel diameter (RVD) between 2.0 mm and 7.0 mm by investigator visual estimate. Target lesion stenosis ≥70% (for vessels below the knee defined as P3 to the ankle joint) or ≥90% (for vessels above the knee) by investigator visual estimate. Target lesion length is ≤150 mm by investigator visual estimate. Target lesion can be all or part of the 150 mm treated zone. 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: - General Exclusion Criteria Rutherford Clinical Category 0, 1 and 6 (target limb). History of endovascular or surgical procedure on the target limb within the last 30 days, or planned within 30 days of the index procedure. Note: inflow treatment of non-target lesions is allowed providing successful treatment. Subject in whom antiplatelet or anticoagulant therapy is contraindicated. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated. Subject has known allergy to urethane, nylon, or silicone. Myocardial infarction within 60 days prior to enrollment. History of stroke within 60 days prior to enrollment. Subject has acute or chronic renal disease with eGFR <30 ml/min/1.73 m2 (using CKD-EPI formula), unless on renal replacement therapy. Subject is pregnant or nursing. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint. Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment. Covid-19 diagnosis within 30 days. Planned use of cutting/scoring balloons, re-entry or atherectomy devices in target lesion(s) during the index procedure. Planned major amputation of target limb. Acute limb ischemia. Occlusion of all the inframalleolar outflow arteries/vessels (i.e., desert foot). Subject already enrolled into this study. Angiographic Exclusion Criteria Failure to treat clinically significant inflow lesions in the ipsilateral iliac, femoral, or popliteal arteries with ≤30% residual stenosis, and no serious angiographic complications (e.g. embolism). Failure to successfully treat significant non-target infra-popliteal lesions, if treated prior to target lesion(s). Successful treatment is defined as obtaining ≤50% residual stenosis with no serious angiographic complications (e.g., embolism). Target lesion includes in-stent restenosis. Evidence of aneurysm or thrombus in target vessel. No calcium or mild calcium in the target lesion. Target lesion within native or synthetic vessel grafts. Failure to successfully cross the guidewire across the target lesion; successful crossing defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-arm<br> | Device: Shockwave Medical Mini S Peripheral IVL Catheter<br>* The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety: Major Adverse Events (MAE) | Major Adverse Events (MAE) at 30 days defined as a composite of: Need for emergency surgical revascularization of target limb 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 | 30 days | 
| Primary Performance: Technical Success | Technical Success defined as final residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion by angiographic core lab | At procedure |