Disrupt PAD+ Study With the Shockwave Medical M5+ Peripheral IVL System

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 > 18.
• Rutherford Clinical Category 2, 3, 4 or 5 of the target limb(s).
• Estimated life expectancy >1 year.
• Subject is intended to undergo treatment with Shockwave M5+ Peripheral IVL System for de novo lesions of the ilio-femoropopliteal arteries.

Angiographic Inclusion Criteria

• Single or multiple de novo target lesion(s) located from the common iliac to the femoropopliteal artery, in one or both limbs.
• Target lesion reference vessel diameter is between 3.5mm and 8.0mm by visual estimate.
• Target lesion is ≥70% stenosis by investigator via visual estimate.
• Target lesion length is ≤200mm for lesions 70-99% stenosed. Target lesion can be all or part of the 200mm treated zone.
• Chronic total occlusion, lesion length is ≤100mm of the total ≤200 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, unless 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 planned use of specialty balloons, re-entry or atherectomy devices in the target lesion(s).

Angiographic Exclusion Criteria

• In-stent restenosis within 10mm of the target zone.
• Target lesions distal to the popliteal 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 more than three target lesions requiring treatment.
• Subject has significant non-target lesion (>50% stenosis or occlusion) within the target limb (e.g. iliac, common femoral or below-the-knee) not successfully treated prior to treatment of the target lesions.
• 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.