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

Exclusion Criteria

• •1. Rutherford Clinical Category 0, 1, and 6.
• •2. Subject has active infection requiring antibiotic therapy.
• •3. 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: Concomitant IVL treatment to facilitate large bore access at the time of procedure is allowed.
• •4. Subject in whom antiplatelet or anticoagulant therapy is contraindicated.
• •5. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
• •6. Subject has known allergy to urethane, nylon, or silicone.
• •7. Myocardial infarction within 60 days prior to enrollment.
• •8. History of stroke within 60 days prior to enrollment.
• •9. Subject has acute or chronic renal disease defined as serum creatinine of \>2.5 mg/dL or \>220 umol/L, unless on dialysis.
• •10. Subject is pregnant or nursing.
• •11. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
• •12. 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.
• •13. The planned use of specialty balloons, re-entry or atherectomy devices in the target lesion(s).
• •14. In-stent restenosis within 10mm of the target zone.
• •15. Target lesions distal to the popliteal artery.
• •16. Evidence of aneurysm or thrombus in target vessel.
• •17. No calcium or mild calcium in the target lesion.
• •18. Target lesion within native or synthetic vessel grafts.
• •19. Subject has more than three target lesions requiring treatment.
• •20. 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.
• •21. 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.