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

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.