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

Exclusion Criteria

• •1. Rutherford Clinical Category 0, 1, 5 and 6.
• •2. Subject has active infection requiring antibiotic therapy.
• •3. Planned target limb major amputation (above the ankle).
• •4. History of prior endovascular or surgical procedure on the index limb within the past 30 days or planned within 30 days of the index procedure.
• •5. Subject has a known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter.
• •6. Subject in whom antiplatelet or anticoagulant therapy is contraindicated.
• •7. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
• •8. Subject has known allergy to urethane, nylon, or silicone.
• •9. Myocardial infarction within 60 days prior to enrollment.
• •10. History of stroke within 60 days prior to enrollment.
• •11. History of thrombolytic therapy within two weeks of enrollment.
• •12. Subject has acute or chronic renal disease defined as serum creatinine of \>2.5 mg/dL or \>220 umol/L, or on dialysis.
• •13. Subject is pregnant or nursing.
• •14. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
• •15. 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.
• •16. The use of specialty balloons, re-entry or atherectomy devices.
• •17. In-stent restenosis within 10mm of the target zone.
• •18. Lesions within 10mm of the ostium of the SFA or within 10mm of the ostium of the anterior tibial artery.
• •19. Evidence of aneurysm or thrombus in target vessel.
• •20. No calcium or mild calcium in the target lesion.
• •21. Target lesion within native or synthetic vessel grafts.
• •22. Subject has significant stenosis (\>50% stenosis) or occlusion of inflow tract before target treatment zone (e.g. iliac or common femoral) not successfully treated.
• •23. Subject requires treatment of a peripheral lesion on the ipsilateral limb distal to target site at the time of the index procedure.
• •24. 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.
• •Observational Study Eligibility Criteria
• •1. Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Shockwave Medical Peripheral Lithoplasty® System as per Instructions for Use (IFU) or investigator's opinion.
• •2. Subject is already enrolled in other investigational (interventional) studies that would interfere with study endpoints.