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Femoropopliteal Artery LesionsNCT02944071

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

A study testing Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter in people with Femoropopliteal Artery Lesions, run by Boston Scientific Corporation at 9 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Femoropopliteal Artery Lesions
What is being tested?
Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
123 participants
Where
9 sitesChina
Study dates
24 Nov 2016to 22 Dec 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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

Who cannot join

  • 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
Show all 30Show fewer
  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

China9 sites

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • Xiangya Hospital Central South University

    Changsha

  • West China Hospital, Sichuan University

    Chengdu, Sichuan

  • The First Affiliated Hospital of Harbin Medicial University

    Harbin, Jilin

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

  • Zhongshan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality

  • Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai

  • Tianjin Medical University General Hospital

    Tianjin

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter
Keywords
femoropopliteal artery lesions, Percutaneous Transluminal Angioplasty, Peripheral Artery Disease, Drug-coated Balloon
Medical subject headings
Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon CatheterDevice

Study groups in NCT02944071
Study groupRoleWhat they receive
(Ranger & Ranger LE) and Ranger DCBExperimentalThe 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.
Receives: Device: Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Within 30 days after treatment

  2. Primary Vessel Patency of the Treated Segment(s)

    Assessed by computed tomography angiography (CTA) at 12 months post-procedure without Target Lesion Revascularization.

    Measured: Within 12 months after treatment

Secondary outcomes (8)

  1. Technical Success

    defined as ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%

    Measured: within 24 hours of the index procedure

  2. 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)

    Measured: within 24 hours of the index procedure

  3. Target Vessel Patency Assessed by Duplex Ultrasound Sonography

    access the target vessel patency at 3 month visit by duplex ultrasound sonography

    Measured: at 3 month post index procedure

  4. 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

    Measured: Within 12 months after treatment

  5. 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

    Measured: Within 12 months after treatment

  6. 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

    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

    Measured: Within 12 months after treatment

  7. 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.

    Measured: Within 12 months after treatment

  8. 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

    Measured: Within 12 months after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2016 (estimated)
  2. Study start24 Nov 2016
  3. Primary completion22 Dec 2020
  4. Study completion22 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02944071
Sponsor's protocol ID
S6052
Status last verified
Oct 2025
First submitted
19 Oct 2016
Last updated
27 Oct 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Criqui MH, Fronek A, Barrett-Connor E, Klauber MR, Gabriel S, Goodman D. The prevalence of peripheral arterial disease in a defined population. Circulation. 1985 Mar;71(3):510-5. doi: 10.1161/01.cir.71.3.510.

    PubMed 3156006

  • Hiatt WR, Hoag S, Hamman RF. Effect of diagnostic criteria on the prevalence of peripheral arterial disease. The San Luis Valley Diabetes Study. Circulation. 1995 Mar 1;91(5):1472-9. doi: 10.1161/01.cir.91.5.1472.

    PubMed 7867189

  • Selvin E, Erlinger TP. Prevalence of and risk factors for peripheral arterial disease in the United States: results from the National Health and Nutrition Examination Survey, 1999-2000. Circulation. 2004 Aug 10;110(6):738-43. doi: 10.1161/01.CIR.0000137913.26087.F0. Epub 2004 Jul 19.

    PubMed 15262830

  • Garcia LA. Epidemiology and pathophysiology of lower extremity peripheral arterial disease. J Endovasc Ther. 2006 Feb;13 Suppl 2:II3-9. doi: 10.1177/15266028060130S204.

    PubMed 16472007

  • Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007 Jan;45 Suppl S:S5-67. doi: 10.1016/j.jvs.2006.12.037. No abstract available.

    PubMed 17223489

  • Kasapis C, Gurm HS. Current approach to the diagnosis and treatment of femoral-popliteal arterial disease. A systematic review. Curr Cardiol Rev. 2009 Nov;5(4):296-311. doi: 10.2174/157340309789317823.

    PubMed 21037847

  • Rooke TW, Hirsch AT, Misra S, Sidawy AN, Beckman JA, Findeiss LK, Golzarian J, Gornik HL, Halperin JL, Jaff MR, Moneta GL, Olin JW, Stanley JC, White CJ, White JV, Zierler RE; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines; Society for Cardiovascular Angiography and Interventions; Society of Interventional Radiology; Society for Vascular Medicine; Society for Vascular Surgery. 2011 ACCF/AHA focused update of the guideline for the management of patients with peripheral artery disease (updating the 2005 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society for Vascular Medicine, and Society for Vascular Surgery. J Vasc Surg. 2011 Nov;54(5):e32-58. doi: 10.1016/j.jvs.2011.09.001. Epub 2011 Sep 29. No abstract available.

    PubMed 21958560

  • Rocha-Singh KJ, Jaff MR, Crabtree TR, Bloch DA, Ansel G; VIVA Physicians, Inc. Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease. Catheter Cardiovasc Interv. 2007 May 1;69(6):910-9. doi: 10.1002/ccd.21104.

    PubMed 17377972

  • Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, Dave R, Ansel G, Lansky A, Cristea E, Collins TJ, Goldstein J, Jaff MR; RESILIENT Investigators. Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv. 2010 Jun 1;3(3):267-76. doi: 10.1161/CIRCINTERVENTIONS.109.903468. Epub 2010 May 18.

    PubMed 20484101

  • Waksman R, Pakala R. Drug-eluting balloon: the comeback kid? Circ Cardiovasc Interv. 2009 Aug;2(4):352-8. doi: 10.1161/CIRCINTERVENTIONS.109.873703. No abstract available.

    PubMed 20031739

  • Stone GW, Ellis SG, Cannon L, Mann JT, Greenberg JD, Spriggs D, O'Shaughnessy CD, DeMaio S, Hall P, Popma JJ, Koglin J, Russell ME; TAXUS V Investigators. Comparison of a polymer-based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease: a randomized controlled trial. JAMA. 2005 Sep 14;294(10):1215-23. doi: 10.1001/jama.294.10.1215.

    PubMed 16160130

  • Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008 Feb 14;358(7):689-99. doi: 10.1056/NEJMoa0706356.

    PubMed 18272892

  • Tenaglia AN, Fortin DF, Califf RM, Frid DJ, Nelson CL, Gardner L, Miller M, Navetta FI, Smith JE, Tcheng JE, et al. Predicting the risk of abrupt vessel closure after angioplasty in an individual patient. J Am Coll Cardiol. 1994 Oct;24(4):1004-11. doi: 10.1016/0735-1097(94)90862-1.

    PubMed 7930190

  • Lincoff AM, Popma JJ, Ellis SG, Hacker JA, Topol EJ. Abrupt vessel closure complicating coronary angioplasty: clinical, angiographic and therapeutic profile. J Am Coll Cardiol. 1992 Apr;19(5):926-35. doi: 10.1016/0735-1097(92)90272-o.

    PubMed 1552113

  • Post MJ, Borst C, Kuntz RE. The relative importance of arterial remodeling compared with intimal hyperplasia in lumen renarrowing after balloon angioplasty. A study in the normal rabbit and the hypercholesterolemic Yucatan micropig. Circulation. 1994 Jun;89(6):2816-21. doi: 10.1161/01.cir.89.6.2816.

    PubMed 8205696

Questions about this trial

What is this clinical trial studying?

A study testing Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter in people with Femoropopliteal Artery Lesions, run by Boston Scientific Corporation at 9 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Adverse Events Through 30 Days Post-procedure (time frame: Within 30 days after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02944071, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.

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