Disrupt PAD BTK II Study With the Shockwave Peripheral IVL System

Open to people ages 18 years and up

• General Inclusion Criteria
• Age of subject is ≥ 18.
• Subject is able and willing to comply with all assessments in the study.
• Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and has signed the approved consent form.
• Critical limb ischemia (CLI) in the target limb from the distal segment (P3) of the popliteal artery to the ankle joint prior to the study procedure with Rutherford Category 4-5; or Rutherford 3 in the target limb from the distal segment (P3) of the popliteal artery to the ankle joint prior to the study procedure.
• Estimated life expectancy >1 year.
  • Angiographic Inclusion Criteria
• Up to 2 below-the-knee target lesion(s) in native vessels in one or both limbs.
• Target lesion reference vessel diameter (RVD) between 2.0 mm and 4.0 mm by investigator visual estimate.
• Target lesion with ≥70% stenosis by investigator visual estimate.
• Target lesion length is ≤200 mm by investigator visual estimate. Target lesion can be all or part of the 200 mm treated zone.
• Distal reconstitution of at least one pedal vessel (<50% stenosis) (desert foot excluded).
• Evidence of at least moderate calcification at the target lesion site by angiography/IVUS OR non-dilatable lesion indicating presence of calcium. Must meet one of the following:
  1. Angiography requires fluoroscopic evidence of calcification on parallel sides of the vessel and extending > 50% the length of the lesion.
  2. IVUS requires presence of ≥270 degrees of calcium over the course of at least 10mm.
  3. Non-dilatable lesion requires attempted treatment with PTA during the index procedure with residual stenosis > 50% and no serious angiographic complications.

• General Exclusion Criteria
• Rutherford Category 0, 1, 2 or 6 (target limb).
• Osteomyelitis or deep soft tissue infection extending proximal from the metatarsals that cannot be treated with an individual toe ray amputation or transmetatarsal amputation (TMA) .
• History of endovascular or surgical procedure on the target limb within the last 30 days, or planned within 30 days of the index procedure.
• Subject in whom antiplatelet or anticoagulant 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 30 days prior to enrollment.
• History of stroke within 60 days prior to enrollment.
• Subject has acute or chronic renal disease with eGFR <30 ml/min/1.73 m2 (using CKD-EPI formula), unless on renal replacement therapy.
• 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.
• Covid-19 diagnosis within 90 days.
• The planned use of cutting/scoring balloons, re-entry or atherectomy devices in target lesions during the index procedure.
• Planned major amputation (of either leg).
• Acute limb ischemia.
• Occlusion of all the inframalleolar outflow arteries/vessels (i.e., desert foot).
• Subject has an anticipated life span of less than one (1) year.
• Subject already enrolled into this study.
  • Angiographic Exclusion Criteria
• Failure to treat clinically significant inflow lesions in the ipsilateral iliac, femoral, or popliteal arteries with ≤30% residual stenosis, and no serious angiographic complications (e.g., embolism).
• Failure to successfully treat significant non-target infra-popliteal lesions prior to treatment of target lesion(s). Successful treatment is defined as obtaining ≤50% residual stenosis with no serious angiographic complications (e.g., embolism ).
• Failed PTA in target lesion during index procedure with angiographic evidence of serious angiographic complications .
• Target lesion includes in-stent restenosis.
• 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.
• 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.