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Clinical Study of the Boston Scientific Paclitaxel-Coated PTA(Percutaneous Transluminal Angioplasty) Balloon Catheter (Ranger™ and Ranger™ SL (OTW) DCB) in China

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ClinicalTrials.gov Identifier: NCT02944071
Recruitment Status : Recruiting
First Posted : October 25, 2016
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Femoropopliteal Artery Lesions Device: Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 123 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty
Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: Ranger™ and Ranger™ Device: Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter



Primary Outcome Measures :
  1. 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 [ Time Frame: Within 30 days after treatment ]
    Collect the subject statue during operation till 30 days after treatment

  2. Primary efficacy endpoint is primary vessel patency of the treated segment(s) as assessed by computed tomography angiography at 12 months post-procedure without Target Lesion Revascularization [ Time Frame: Within 12 months after treatment ]
    Compare the reports of computed tomography angiography at screening visit and 12 months visit, to assess the vessel patency of the target segment


Secondary Outcome Measures :
  1. 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%

  2. 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)

  3. 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

  4. 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

  5. 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

  6. Time to first clinically-driven Target Lesion Revascularization through 12 months post-procedure [ Time Frame: Within 12 months after treatment ]
    calculate the first time to operate Target Lesion Revascularization within 12 month after treatment

  7. Clinical success [ Time Frame: Within 12 months after treatment ]
    defined as improved Rutherford classification by at least +1 class compared to baseline

  8. Hemodynamic success [ Time Frame: Within 12 months after treatment ]
    defined as positive change in Ankle-Brachial Index

  9. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02944071


Contacts
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Contact: Yisi Wang yisi.wang@bsci.com

Locations
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China
Xiangya Hospital Central South University Recruiting
Changsha, China
Contact: Jianhua Huang       huangjianhua@medmail.com.cn   
Sponsors and Collaborators
Boston Scientific Corporation

Publications:
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. Review.
Lutonix 2014 Panel Presentation Summary of Safety and Effectiveness Data (SSED) http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/medicaldevices/medicaldevicesadvisorycommittee/circulatorysystemdevicespanel/ucm400421.pdf.

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02944071     History of Changes
Other Study ID Numbers: S6052
First Posted: October 25, 2016    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017

Keywords provided by Boston Scientific Corporation:
femoropopliteal artery lesions
Percutaneous Transluminal Angioplasty
Peripheral Artery Disease
Drug-coated Balloon

Additional relevant MeSH terms:
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Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action