Ranger™ and Ranger™ SL (OTW) DCB) in China

Prospective, Non-randomized, Multicenter Clinical Study of the Boston Scientific Paclitaxel-Coated PTA Balloon Catheter (Ranger™ and Ranger™ SL (OTW) DCB) in China

This clinical study is a prospective, non-randomized, multicenter study to demonstrate the acceptable safety and performance of angioplasty with the Ranger DCB in native femoropopliteal artery lesions. It is intended that all patients with qualifying lesions would be considered for enrollment and treated with the Ranger DCB catheter. Approximately 123 patients with femoropopliteal artery lesions will be enrolled. All lesions will be treated with the Ranger DCB. Up to 15 clinical sites located in China are expected to participate.

study objectives: The primary objective of this study is to demonstrate acceptable safety and performance of the Ranger™（Ranger & Ranger LE） and Ranger™ SL (OTW) paclitaxel-coated PTA balloon catheter used for angioplasty of femoropopliteal artery lesions.

Primary endpoints: The primary safety endpoint is the rate of following major adverse events through 30 days post-procedure:

• all device and/or procedure related mortality
• target limb major amputation at
• Clinically-driven Target Lesion Revascularization (TLR)

The primary efficacy endpoint is primary lesion patency of the treated segment(s) as assessed by computed tomography angiography (CTA) at 12 months post-procedure without clinically-driven TLR.

Inclusion Criteria:

• Subjects must be age 18 or older
• Subject is willing and able to provide informed consent
• Subject is available and willing to attend all required follow-up visits
• Subject has a clinically significant symptomatic leg ischemia
• Subject has a Rutherford clinical category of 2 - 4
• If the index lesion is restenotic, the prior PTA must have been > 90 days prior to treatment in the current study
• Only one lesion per limb can be treated under this protocol, which means that one index lesion, on one index limb will be "in treatment". However, both limbs may be treated during either the index procedure and/or subsequent procedures
• Successful intraluminal wire crossing of the target lesion

Angiographic Inclusion Criteria:

• Al1.The index lesion is a clinically and hemodynamically de novo stenotic or restenotic lesion located in the native nonstented superficial femoral artery or proximal popliteal artery between the Hunter's Canal and the popliteal fossa (i.e. within the P1 segment), with the following characteristics by visual assessment:

  • Degree of stenosis ≥ 70%
  • Target vessel diameter ≥ 2.0 mm and ≤ 8.0 mm
  • Lesion length ≥ 20 mm and ≤ 200 mm, to be covered by one or two balloon(s) (with minimal overlap)
  • For diffuse lesion or multiple lesions in the same target vessel, the total lesion length, including the distance between lesions, must be ≤ 200 mm

• AI2. The subject has at least one patent infrapopliteal artery (< 50% stenosis) to the foot prior to index procedure

Exclusion Criteria:

• Subjects who have undergone prior vascular surgery of the SFA/PPA（Superficial Femoral Artery / Proximal Popliteal Artery） in the index limb to treat atherosclerotic disease
• History of major amputation in the same limb as the target lesion
• Presence of aneurysm in the target vessel(s)
• Acute ischemia and/or acute thrombosis in any artery of the lower limbs
• Acute Myocardial Infarction within 30 days before the index procedure
• History of hemorrhagic stroke within 3 months
• History of thrombolysis or angina within 2 weeks of enrollment
• Persistent, intraluminal thrombus of the proposed target lesion post thrombolytic therapy
• Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated
• Known allergies against Paclitaxel or other components of the used medical devices
• Intolerance to antiplatelet, anticoagulant, or thrombolytic medications that would be administered during the trial
• Platelet count < 80,000 mm3 or > 700,000 mm3
• Concomitant renal failure with a serum creatinine > 2.0 mg/dL
• Receiving dialysis or immunosuppressant therapy
• Life expectancy of less than one year
• Women of child-bearing potential cannot use a reliable method of contraception from the time of screening through 12 months after the index procedure.
• Woman who is pregnant or nursing. (Pregnancy test must be performed within 72 hours prior to the index procedure, except for women who definitely do not have child-bearing potential).
• Previously planned stenting of the index lesion (stents will be allowed for bailout situations like flow-limiting dissection)
• Use of adjunctive therapies (debulking, laser, cryoplasty, re-entry devices)
• Subjects who had any major procedures (cardiac, aorta, peripheral) within 30 days prior to the index procedure
• Planned or expected procedures (cardiac, aorta, peripheral) within 30 days post the index procedure
• Presence of outflow lesions requiring intervention within 30 days of the index procedure
• Perforated vessel as evidenced by extravasation of contrast media
• Heavily calcified target lesions resistant to PTA
• Current participation in another drug or device trial that has not completed the primary endpoint, including any clinical study using drug-coated or drug-eluting technology, that may potentially confound the results of this trial, or that would limit the subject's compliance with the follow-up requirements
• Current or past intervention using drug-coated/drug-eluting technologies in the index limb
• Target lesion with in-stent restenosis (any stent or stent-graft)

Angiographic Exclusion Criteria:

• AE1. Subjects with ipsilateral iliac inflow lesions , and unsuccessful treatment prior to the index procedure (i.e., residual stenosis ≥ 30% post treatment
• AE2. Subjects with no patent infrapopliteal artery (i.e., ≥ 50% stenosis) to the foot prior to index procedure