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

A Prospective, Multicenter, Single-arm Clinical Trial of Jetstream Atherectomy System for the Treatment of Japanese Patients With Symptomatic Occlusive Atherosclerotic Lesions in the Superficial Femoral and/ or Proximal Popliteal Arteries

The purpose of this study is to evaluate the safety and effectiveness of the Jetstream Atherectomy System for the treatment of Japanese patients with symptomatic occlusive atherosclerotic lesions in native superficial femoral artery (SFA) and/or proximal popliteal arteries (PPA).

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