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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Femoropopliteal Artery Lesions

Intervention / Treatment
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* Device: Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: (Ranger & Ranger LE) and Ranger DCB<br>The working length is 80cm and 135cm for Ranger DCB catheter and 90 cm and 150cm for Ranger SL and Ranger LE DCB catheter. Multiple interventions: Prior to or during Index Procedure: Prior to treatment of the index limb, successful (< 30% residual stenosis) treatment of ipsilateral iliac inflow lesions may be performed Prior to treatment of the index limb, successful treatment of the arteries of the non-index limb may be performed Prior to treatment of the index limb, absence of clinical complications such as embolism, thrombosis, severe dissection, vessel rupture must be confirmed. | Device: Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Within 30 days after treatment | 
| Primary Vessel Patency of the Treated Segment(s) | Assessed by computed tomography angiography (CTA) at 12 months post-procedure without Target Lesion Revascularization. | Within 12 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success | defined as ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30% | within 24 hours of the index procedure | 
| Procedural Success | defined as technical success with no Major Adverse Events (including all-cause death, clinically-driven Target Lesion Revascularization, target limb major amputation or thrombosis at target lesion) | within 24 hours of the index procedure | 
| Target Vessel Patency Assessed by Duplex Ultrasound Sonography | access the target vessel patency at 3 month visit by duplex ultrasound sonography | at 3 month post index procedure | 
| All-cause Death at 30 Days, 3, 6 and 12 Months | calculate the rate of all-cause death at 30 days, 3, 6 and 12 months after treatment | Within 12 months after treatment | 
| Clinically-driven Target Lesion Revascularization at 3, 6 and 12 Months | calculate the rate of Target Lesion Revascularization at 30 days, 3, 6 and 12 months after treatment | Within 12 months after treatment | 
| Clinical Success | defined as improved Rutherford classification by at least +1 class at pre-discharge, 3 and 12 months as compared to baseline. RUTHERFORD / BECKER CLASSIFICATION Category Objective Criteria 0 Normal Treadmill /stress test Completes treadmill exercise; ankle pressure (AP) after exercise < 50 mm Hg, but > 25 mm Hg less than BP Between categories 1 and 3 Cannot complete treadmill exercise and AP after exercise < 50 mm Hg Resting AP < 40 mm Hg, flat or barely pulsatile ankle or metatarsal pulse volume recording (PVR); toe pressure (TP) < 30 mm Hg Nonhealing ulcer, focal gangrene with diffuse pedal edema. Resting AP < 60 mm Hg, ankle or metatarsal (MT) PVR flat or barely pulsatile; TP < 40 mm Hg Extending above MT level. Same as Category 5 | Within 12 months after treatment | 
| Hemodynamic Success | defined as positive change in Ankle-Brachial Index at pre-discharge, 3 months, 12 months as compared to baseline. The ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows: Ankle: The systolic pressure will be measured in the target limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation. Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation. | Within 12 months after treatment | 
| Major Adverse Events Through 12 Months | Major Adverse Events , including all-cause death, clinically-driven Target Lesion Revascularization, target limb major amputation or thrombosis at target lesion | Within 12 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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femoropopliteal artery lesions, Percutaneous Transluminal Angioplasty, Peripheral Artery Disease, Drug-coated Balloon