Trial Outcomes & Findings for Safety and Performance Study of the Shockwave Lithoplasty System (NCT NCT02071108)

Three investigational sites in Austria and New Zealand participated in the study. Between January 2014 and September 2014, a total of 35 subjects and 39 lesions of the superficial femoral and popliteal arteries were enrolled in the Full Analysis Cohort of the study and treated with the investigational device.

Safety and Performance Study of the Shockwave Lithoplasty System

Need for emergency surgical revascularization of target limb. Unplanned target limb amputation (above the ankle). Symptomatic thrombus or distal emboli, defined as clinical signs or symptoms of thrombus or distal emboli detected in the treated limb in the area of the treated lesion, or distal to the treated lesion, after the index procedure or noted angiographically, and requiring mechanical or pharmacologic means to improve flow. Perforations and dissections of grade D or greater that require an intervention to resolve, including bail-out stenting.

The ability of the Shockwave Medical Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of \<50% (with or without adjunctive Percutaneous Transluminal Angioplasty therapy) as assessed by quantitative angiography via core lab evaluation.

The ability of the Shockwave Medical Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of \<50% (without adjunctive percutaneous transluminal angioplasty therapy) as assessed via quantitative angiography via core lab evaluation.

The ability of the Shockwave Medical Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of \<50% (with or without adjunctive percutaneous transluminal angioplasty therapy) as assessed by the investigator via visual estimate and freedom from procedural major adverse events.

The ability of the Shockwave Medical Lithoplasty System to delivery ShockWave treatment to the desired location in the target vessel. Up to two Shockwave Medical Lithoplasty Systems maybe used to complete treatment in the target vessel.

Freedom from Major Adverse Events at 30 days.

Freedom from Target Lesion Revascularization (TLR) at 30 days

Vessel patency at 30 days by Doppler Ultrasound defined as freedom from greater than 50% restenosis (as assessed by Duplex ultrasound peak systolic velocity ratio of ≥2.5).

Change in Ankle Brachial Index (ABI) of the target limb at 30 days. The Ankle Brachial Index (ABI) is the systolic pressure at the ankle, divided by the systolic pressure at the arm.

Change in Rutherford Clinical Category (RCC) at 30 days. RCC identifies three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. Grade I includes Category 0 - Asymptomatic, Category 1 - Mild claudication, Category 2 - Moderate claudication, and Category 3 - Severe claudication. Grade II includes Category 4 - Ischemic rest pain and Category 5 - Minor tissue loss. Grade III includes Category 6 - Ulceration or grangrene. Change of at least 2 categories considered statistically significant.

Freedom from Major Adverse Events at 6 months

Freedom from Target Lesion Revascularization (TLR) at 6 months

Vessel patency at 6 months at Doppler Ultrasound defined as freedom from greater than 50% restenosis (as assessed by Duplex ultrasound peak systolic velocity ratio of =2.5).

Change in Ankle Brachial Index (ABI) of the target limb at 6 months. The Ankle Brachial Index (ABI) is the systolic pressure at the ankle, divided by the systolic pressure at the arm.

Change in Rutherford Clinical Category (RCC) at 6 months. RCC identifies three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. Grade I includes Category 0 - Asymptomatic, Category 1 - Mild claudication, Category 2 - Moderate claudication, and Category 3 - Severe claudication. Grade II includes Category 4 - Ischemic rest pain and Category 5 - Minor tissue loss. Grade III includes Category 6 - Ulceration or grangrene. Change of at least 2 categories considered statistically significant.

The clinical protocol provided for an Exploratory Secondary Endpoint to assess the ability of the device to achieve ≤30% residual stenosis without adjunctive PTA as assessed by the investigator via visual estimate.