Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD III)

Randomized Study Arm Eligibility Criteria

General 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 greater than or equal to 18.
• Rutherford Clinical Category 2, 3, or 4 of the target limb.
• Estimated life expectancy >1 year.
• Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guideline.
• Subject is intended to undergo treatment with Lithoplasty followed by DCB, or DCB with standard balloon pre-dilatation.

Angiographic Inclusion Criteria

• 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 4.0mm and 7.0mm by visual estimate.
• Target lesion is ≥70% stenosis by investigator via visual estimate.
• Target lesion length is ≤180mm for lesions 70-99% stenosed. Target lesion can be all or part of the 180mm treated zone.
• Chronic total occlusion, lesion length is ≤100mm of the total ≤180 mm target lesion.
• Subject has at least one patent tibial vessel on the target leg with runoff to the foot, 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 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 pre- and post-treatment.
• The use of specialty balloons, re-entry or atherectomy devices.

Angiographic Exclusion Criteria

• In-stent restenosis within 10mm of the target zone.
• Lesions within 10mm of the ostium of the SFA or within 10mm of the ostium of the anterior tibial artery.
• 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.
• Subject has significant stenosis (>50% stenosis) or occlusion of inflow tract before target treatment zone (e.g. iliac or common femoral) not successfully treated.
• Subject requires treatment of a peripheral lesion on the ipsilateral limb distal to target site at the time of the index procedure.
• 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.

Subjects who do not meet the inclusion/exclusion criteria for the randomized study may satisfy the eligibility criteria for the observational study.

Observational Study Eligibility Criteria

Inclusion Criteria

• Subjects intended to be treated with the Shockwave Medical Peripheral Lithoplasty® System for de-novo or restenotic lesions of the femoral, ilio-femoral, popliteal, and infra-popliteal arteries.
• Subjects presenting with claudication or CLI by Rutherford Clinical Category 2,3,4,5, or 6 of the target limb.
• Age of subject is > 18.
• Subject or subject's legal representative have been informed of the nature of the study, agrees to participate, and has signed the approved study consent form.
• Calcification is at least moderate, defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending