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

Not Applicable

Completed

Conditions: Femoropopliteal Artery Lesions

Interventions: Device: Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter

Registration Number: NCT02944071

Lead Sponsor: Boston Scientific Corporation

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 123

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
(Ranger & Ranger LE) and Ranger DCB	Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter	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.

Primary Outcome Measures

Name	Time	Method
Major Adverse Events Through 30 Days Post-procedure	Within 30 days after treatment	* all device and/or procedure related mortality * target limb major amputation at * Clinically-driven Target Lesion Revascularization
Primary Vessel Patency of the Treated Segment(s)	Within 12 months after treatment	Assessed by computed tomography angiography (CTA) at 12 months post-procedure without Target Lesion Revascularization.

Secondary Outcome Measures

Name	Time	Method
Technical Success	within 24 hours of the index procedure	defined as ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%
Clinical Success	Within 12 months after treatment	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 1. Completes treadmill exercise; ankle pressure (AP) after exercise \< 50 mm Hg, but \> 25 mm Hg less than BP 2. Between categories 1 and 3 3. Cannot complete treadmill exercise and AP after exercise \< 50 mm Hg 4. Resting AP \< 40 mm Hg, flat or barely pulsatile ankle or metatarsal pulse volume recording (PVR); toe pressure (TP) \< 30 mm Hg 5. 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 6. Extending above MT level. Same as Category 5
Hemodynamic Success	Within 12 months after treatment	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.
Target Vessel Patency Assessed by Duplex Ultrasound Sonography	at 3 month post index procedure	access the target vessel patency at 3 month visit by duplex ultrasound sonography
Clinically-driven Target Lesion Revascularization at 3, 6 and 12 Months	Within 12 months after treatment	calculate the rate of Target Lesion Revascularization at 30 days, 3, 6 and 12 months after treatment
All-cause Death at 30 Days, 3, 6 and 12 Months	Within 12 months after treatment	calculate the rate of all-cause death at 30 days, 3, 6 and 12 months after treatment
Procedural Success	within 24 hours of the index procedure	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)
Major Adverse Events Through 12 Months	Within 12 months after treatment	Major Adverse Events , including all-cause death, clinically-driven Target Lesion Revascularization, target limb major amputation or thrombosis at target lesion

Trial Locations

Locations (9): Beijing Tongren Hospital, Capital Medical University
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BeiJing, Beijing, China
The First Affiliated Hospital of Zhengzhou University
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Zhengzhou, Henan, China
Jiangsu Province Hospital
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Nanjing, Jiangsu, China
The First Affiliated Hospital of Harbin Medicial University
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Harbin, Jilin, China
Zhongshan Hospital Affiliated to Fudan University
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Shanghai, Shanghai, China
Xiangya Hospital Central South University
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Changsha, China
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
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Shanghai, China
Tianjin Medical University General Hospital
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Tianjin, China
West China Hospital, Sichuan University
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Chengdu, Sichuan, China