Safety and Feasibility of the Shockwave Lithoplasty® System for the Treatment of Peripheral Vascular Stenosis

Shockwave Medical, Inc. intends to conduct a prospective, single-arm, multi-center, clinical study designed to evaluate the early safety and performance of the Shockwave Lithoplasty® System in subjects with moderate to heavily calcified peripheral arteries with 2.5mm to 3.5mm reference vessel diameter at the target site. The Shockwave Lithoplasty® System is indicated for lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic peripheral arteries in patients who are candidates for percutaneous therapy. Up to twenty subjects will be enrolled and treated with Lithoplasty® System.

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 1 - 5.

Angiographic Inclusion Criteria:

• Single or multiple target lesion(s) is/are located in a de novo artery distal to the trifurcation vessels and extends to and ends above the ankle
• Target vessel reference diameter is between 2.5mm and 3.5mm by visual estimate
• Target lesion with diameter stenosis ≥50% by investigator via visual estimate
• If inflow disease >50% proximal to the trifurcation vessels is present, and it can be treated with POBA, stent or Lithoplasty and without complications.
• Target lesion is ≤150mm in length
• Subject has at least one patent tibial vessel (>50%) with run-off to the foot.
• No evidence of aneurysm or acute thrombus in target vessel.
• Any presence of calcification within the target lesion as assessed by imaging (radiograph, CT or angiography).

Exclusion criteria

• Rutherford Clinical Category 6.
• Target lesion is within only lower extremity vessel with < 50% stenosis.
• Gangrene of the lower extremity.
• Planned major amputation of the target leg.
• Previously implanted stent in the treatment lesion
• Target lesion length exceeds 150mm.
• Patient has chronic total occlusion of target lesion.
• Patient has significant stenosis (>50% stenosis) or occlusion of inflow tract (e.g., iliac or common femoral) not successfully treated with POBA, stent or Lithoplasty and without complications.
• Patient in whom antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated.
• Patient has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
• Patient has known allergy to urethane, nylon, or silicone.
• Patient is pregnant or nursing.
• Patient is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.