Clinical trial NCT02944071: Ranger™ and Ranger™ SL (OTW) DCB) in China
Official title: Prospective, Non-randomized, Multicenter Clinical Study of the Boston Scientific Paclitaxel-Coated PTA Balloon Catheter (Ranger™ and Ranger™ SL (OTW) DCB) in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoropopliteal Artery Lesions
Keywords: femoropopliteal artery lesions
Percutaneous Transluminal Angioplasty
Peripheral Artery Disease
Drug-coated Balloon
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2016-10-25
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Major Adverse Events Through 30 Days Post-procedure
timeFrame: Within 30 days after treatment
measure: Primary Vessel Patency of the Treated Segment(s)
timeFrame: Within 12 months after treatment
Secondary outcomes:
measure: Technical Success
timeFrame: within 24 hours of the index procedure
measure: Procedural Success
timeFrame: within 24 hours of the index procedure
measure: Target Vessel Patency Assessed by Duplex Ultrasound Sonography
timeFrame: at 3 month post index procedure
measure: All-cause Death at 30 Days, 3, 6 and 12 Months
timeFrame: Within 12 months after treatment
measure: Clinically-driven Target Lesion Revascularization at 3, 6 and 12 Months
timeFrame: Within 12 months after treatment
measure: Clinical Success
timeFrame: Within 12 months after treatment
measure: Hemodynamic Success
timeFrame: Within 12 months after treatment
measure: Major Adverse Events Through 12 Months
timeFrame: Within 12 months after treatment
Other outcomes:
Locations:
city: BeiJing
country: China
facility: Beijing Tongren Hospital, Capital Medical University
state: Beijing
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Harbin
country: China
facility: The First Affiliated Hospital of Harbin Medicial University
state: Jilin
city: Shanghai
country: China
facility: Zhongshan Hospital Affiliated to Fudan University
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Changsha
country: China
facility: Xiangya Hospital Central South University
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
Study officials:
affiliation: Beijing Anzehn hospital
name: Zhong Chen, dr.
role: PRINCIPAL_INVESTIGATOR
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