Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME)

A prospective, multicenter, single-arm trial evaluating the safety and efficacy of the Jetstream Atherectomy System in the treatment of symptomatic occlusive atherosclerotic lesions ≤150 mm in length located in the femoropopliteal arteries in subjects with symptoms classified as Rutherford categories 2-4.

Inclusion criteria

• Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2-4
• Stenotic, restenotic or occlusive lesion(s) located in the native SFA and/or PPA of which meet all of the following criteria:

• Calcified lesions with degree of stenosis ≥70% or occlusions
• Guidewire must cross lesion(s) within the true lumen, without a sub-intimal course
• Vessel diameter ≥3.0 mm and ≤6.0 mm
• Total lesion length (or series of lesions) ≤150mm
• Target lesion located at least 3 cm above the inferior edge of the femur by visual estimate
• Patent infrapopliteal and popliteal artery

Exclusion criteria

• Target lesion/vessel with in-stent restenosis
• Target lesion/vessel previously treated with drug-coated balloon <12 months prior to the procedure
• Target lesion/vessel previously treated with any stent placement, atherectomy, laser or other debulking devices prior to the procedure
• Subjects who have undergone surgery or endovascular of the SFA/PPA in the target vessel to treat atherosclerotic disease within 3 months prior to the index procedure
• Use of drug-coated devices, atherectomy, laser or other debulking devices other than the Jetstream System, chronic total occlusion (CTO) devices or cutting balloon, Angioscore or similar devices in the target limb SFA/PPA during the index procedure
• History of major amputation in the target limb
• Subject has a history of coagulopathy or hypercoagulable bleeding disorder
• Subject with untreatable hemorrhagic disease or platelet count <80,000mm3 or >600,000mm3 as baseline assessment.
• Concomitant renal failure with a serum creatinine >2.0 mg/dL
• Receiving dialysis or immunosuppressant therapy
• History of myocardial infarction, or stroke/cerebrovascular accident (CVA) within 6 months prior to study enrollment
• Unstable angina pectoris at the time of the enrollment
• Septicemia at the time of enrollment
• Presence of other hemodynamically significant outflow lesions in the target limb requiring a planned surgical intervention or endovascular procedure within 30 days after the index procedure
• Presence of aneurysm in the target vessel
• Acute ischemia and/or acute thrombosis of the SFA/PPA prior to the index procedure
• Perforated vessel as evidenced by extravasation of contrast media prior to the index procedure