Shockwave Lithoplasty DISRUPT Trial for PAD (DISRUPT PAD 2)

Inclusion Criteria

• Subject is able and willing to comply with all assessments in the study.
• Subject or subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form.
• Age of subject is >18.
• Rutherford Clinical Category 2, 3, or 4.
• Resting ankle-brachial index (ABI) of ≤0.90, or ≤0.75 after exercise, of the target leg.
• Estimated life expectancy >1 year.

Angiographic Inclusion Criteria:

• Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guideline.
• Target lesion that is located in a native de novo superficial femoral artery (SFA) or popliteal artery (popliteal artery extends to and ends proximal to the ostium of the anterior tibial artery).
• Target lesion reference vessel diameter is between 3.50mm and 7.0mm by visual estimate.
• Target zone is ≤150mm in length. Target lesion can be all or part of the 150mm zone.
• Target lesion is ≥70% stenosis by investigator via visual estimate.
• Subject has at least one patent tibial vessel on the target leg with runoff to the ankle (not supported by collateral circulation.) Tibial vessel patency is defined as no stenosis >50%.
• Ability to pass the guidewire across the atherosclerotic lesion.
• No evidence of aneurysm or acute or chronic thrombus in target vessel.
• Calcification is at least moderate. (Presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending ≥ 50% the length of the lesion.)

Exclusion Criteria

• Rutherford Clinical Category 5 and 6.
• Subject has active infection in the target leg.
• Planned major amputation of the target leg (transmetatarsal or higher).
• The use of chronic total occlusion (CTO) re-entry devices.
• CTOs greater than 80 mm in length.
• Any in-stent restenosis within the target zone.
• Lesions within 10 mm of ostium of the SFA.
• Highly tortuous arteries (bends greater than 30 degrees over the arc length of the balloon).
• Target lesion within native or synthetic vessel grafts.
• History of prior endovascular or surgical procedure on the index limb within the past 30 days.
• Subject has significant stenosis (>50% stenosis) or occlusion of inflow tract before target treatment zone (e.g. iliac or common femoral) not successfully treated with Plain old Balloon Angioplasty (POBA) or stent and without complications.
• Subject requires treatment of a peripheral lesion on the ipsilateral limb distal and beyond the 150mm target zone at the time of the enrollment/index procedure.
• Subject has a known coagulopathy or has a bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter, or International Normalized Ratio (INR) >1.5.
• Subject in whom antiplatelet, anticoagulant, or thrombolytic 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.
• History of unstable coronary artery disease or other uncontrollable comorbidity resulting in hospitalization within the last 60 days prior to enrollment.
• History of thrombolytic therapy within two weeks of enrollment.
• Subject has acute or chronic renal disease (e.g., as measured by a serum creatinine of >2.5 mg/dL or >220 umol/L), or on dialysis.
• 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