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

October 23, 2025 updated by: Boston Scientific Corporation

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Changsha, China
        • Xiangya Hospital Central South University
      • Shanghai, China
        • Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
      • Tianjin, China
        • Tianjin Medical University General Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Beijing Tongren Hospital, Capital Medical University
    • Henan
      • Zhengzhou, Henan, China
        • The first affiliated hospital of Zhengzhou university
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Jiangsu Province Hospital
    • Jilin
      • Harbin, Jilin, China
        • The First Affiliated Hospital of Harbin Medicial University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Zhongshan Hospital Affiliated to Fudan University
    • Sichuan
      • Chengdu, Sichuan, China
        • West China Hospital, Sichuan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: (Ranger & Ranger LE) and Ranger DCB

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Events Through 30 Days Post-procedure
Time Frame: Within 30 days after treatment
  • 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)
Time Frame: Within 12 months after treatment
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
Time Frame: 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%
within 24 hours of the index procedure
Procedural Success
Time Frame: 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)
within 24 hours of the index procedure
Target Vessel Patency Assessed by Duplex Ultrasound Sonography
Time Frame: at 3 month post index procedure
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
Time Frame: Within 12 months after treatment
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
Time Frame: Within 12 months after treatment
calculate the rate of Target Lesion Revascularization at 30 days, 3, 6 and 12 months after treatment
Within 12 months after treatment
Clinical Success
Time Frame: 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
Within 12 months after treatment
Hemodynamic Success
Time Frame: 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.
Within 12 months after treatment
Major Adverse Events Through 12 Months
Time Frame: 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
Within 12 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Zhong Chen, dr., Beijing Anzehn hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2016

Primary Completion (Actual)

December 22, 2020

Study Completion (Actual)

December 22, 2020

Study Registration Dates

First Submitted

October 19, 2016

First Submitted That Met QC Criteria

October 23, 2016

First Posted (Estimated)

October 25, 2016

Study Record Updates

Last Update Posted (Estimated)

October 27, 2025

Last Update Submitted That Met QC Criteria

October 23, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S6052

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Femoropopliteal Artery Lesions

Clinical Trials on Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe