Jetstream in Treatment of Occlusive Atherosclerotic Lesions in the SFA and/or PPA

Prospective, Non-randomized, Multicenter Clinical Study of the JETSTREAM™ Atherectomy System (Jetstream) in Treatment of Occlusive Atherosclerotic Lesions in the Superficial Femoral and/or Proximal Popliteal Arteries in Chinese Patients

This clinical study is a prospective, non-randomized, multicenter, single-arm study to demonstrate the acceptable safety and performance of the JETSTREAM™ Atherectomy System (Jetstream) used during percutaneous peripheral vascular intervention in patients with occlusive atherosclerotic lesions in the native SFA and/or PPA. It is intended that all patients with qualifying lesions would be considered for enrollment and treated with the Jetstream System.

study objectives: To evaluate the safety and effectiveness of JETSTREAM™ Atherectomy System (Jetstream) for treating symptomatic Chinese patients with occlusive atherosclerotic lesions in native superficial femoral artery (SFA) and/ or proximal popliteal arteries (PPA)during percutaneous peripheral vascular intervention.

Planed Indications for use: The Jetstream System is intended for use in atherectomy of the peripheral vasculature and to break apart and remove atherosclerotic disease, debris, and thrombus from the SFA and/or PPA.

Primary Safety Endpoint: Major Adverse Event (MAE), defined as all-cause death, target limb unplanned major amputation and/or target lesion revascularization (TLR), within 30 days post index procedure

Primary Effectiveness Endpoint: Acute reduction of percent diameter stenosis (%DS) post atherectomy but prior to any adjunctive therapy, when compared to its baseline diameter stenosis (absolute mean percentage).

Inclusion Criteria:

1. Subjects age 18 and older

2. Subject or the subject's legal representative is willing and able to provide consent before any study-specific test or procedure is performed, signs the consent form, and agrees to attend all required follow-up visits

3. Subject has documented chronic, symptomatic lower limb ischemia defined as Rutherford categories 2 - 4, and is eligible for percutaneous peripheral vascular intervention

4. Stenotic, restenotic or occlusive lesion(s) located in the native SFA and/or PPA, and meet all of following angiographic criteria by visual assessment:

   i. Atherosclerotic lesion with diameter stenosis ≥70% ii. Guidewire must cross lesion(s) within the true lumen, without a sub-intimal course by physicians performed, based on visual estimate iii. Minimum vessel diameter proximal to the lesion ≥ 3 mm and < and =6 mm iv. Lesion length of single or multiple focal stenosis or chronic total occlusion (CTO) lesion can be up to 15 cm long v. Target lesion located at least 3 cm above the inferior edge of the femur

5. Patent infrapopliteal and popliteal artery, i.e., single distal runoff or better with at least one of three vessels patent (< 50% stenosis by visual assessment) to the ankle or foot with no planned intervention

Exclusion Criteria:

1. Target lesion is located in the iliac artery or above the SFA
2. Target lesion stenosis < 70%
3. Target lesion is moderately to severely angulated (> 30°) or torturous at treatment segment
4. Target lesion/vessel previously treated with drug-coated balloon within 12 months prior to the index procedure
5. Target lesion/vessel previously treated with atherectomy, laser or other debulking devices prior to the index procedure
6. Target lesion/vessel with in-stent restenosis
7. Subjects who have undergone prior surgery or endovascular intervention of SFA/PPA in the target limb to treat atherosclerotic disease within 3 month prior to the index procedure
8. Use of drug-coated devices, or laser or any other debulking devices other than Jetstream System (such as CTO devices or cutting balloon) in the target limb during the index procedure
9. History of major amputation in the target limb
10. Documented life expectancy less than 12 months due to other medical co-morbid condition(s)
11. Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated
12. Known history of coagulopathy or hypercoagulable bleeding disorder
13. Known hypersensitivity/allergy to the investigational devices or protocol related therapies (e.g., nitinol, stainless steel or other stent materials, and antiplatelet, anticoagulant, thrombolytic medications)
14. Platelet count < 80,000 mm3 or > 600,000 mm3 or history of bleeding diathesis
15. Undergoing hemodialysis or concomitant renal failure with a serum creatinine > 2.0 mg/dL (176.8umol/L)
16. History of myocardial infarction (MI), stroke/cerebrovascular accident (CVA) or gastrointestinal bleeding within 6 months prior to the enrollment
17. Unstable angina pectoris at the time of enrollment.
18. History of severe trauma, fracture, major surgery or biopsy of a parenchymal organ within past 14 days
19. Pregnant, breast feeding, or plan to become pregnant in the next 12 months
20. Current participation in another investigational drug or device clinical study that has not completed the primary endpoint at the time of enrollment or that clinically interferes with the current study endpoints (Note: studies requiring extended follow-up for products that were investigational, but have become commercially available since then are not considered investigational studies)
21. Septicemia at the time of enrollment
22. Presence of outflow lesions in the target limb requiring intervention during the index procedure
23. Presence of other hemodynamically significant lesions in the target limb requiring intervention within 30 days of enrollment
24. Acute ischemia and/or acute thrombosis of the target lesion/vessel prior to the index procedure
25. Presence of aneurysm in the target vessel
26. Perforated vessel as evidenced by extravasation of contrast media prior to the enrollment