Study Results
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
123 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-11-24
Study Completion Date
2020-12-22
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Femoropopliteal Artery Lesions
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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(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.
Group Type
EXPERIMENTAL
Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter
Intervention Type
DEVICE
Interventions
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Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter
Intervention Type
DEVICE
Eligibility Criteria
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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
* 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
* 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
* 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)
* 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
* 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)
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Zhong Chen, dr.
Role: PRINCIPAL_INVESTIGATOR
Beijing Anzehn hospital
Locations
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Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Site Status
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Site Status
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Site Status
The First Affiliated Hospital of Harbin Medicial University
Harbin, Jilin, China
Site Status
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Site Status
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Site Status
Xiangya Hospital Central South University
Changsha, , China
Site Status
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, , China
Site Status
Tianjin Medical University General Hospital
Tianjin, , China
Site Status
Countries
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China
References
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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.
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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.
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Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group; Bell K, Caporusso J, Durand-Zaleski I, Komori K, Lammer J, Liapis C, Novo S, Razavi M, Robbs J, Schaper N, Shigematsu H, Sapoval M, White C, White J, Clement D, Creager M, Jaff M, Mohler E 3rd, Rutherford RB, Sheehan P, Sillesen H, Rosenfield K. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl 1:S1-75. doi: 10.1016/j.ejvs.2006.09.024. Epub 2006 Nov 29. No abstract available.
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BACKGROUND
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.
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BACKGROUND
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.
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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.
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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.
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BACKGROUND
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.
Reference Type
BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
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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.
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BACKGROUND
Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008 Sep 23;118(13):1358-65. doi: 10.1161/CIRCULATIONAHA.107.735985. Epub 2008 Sep 8.
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Leiner T, Kessels AG, Nelemans PJ, Vasbinder GB, de Haan MW, Kitslaar PE, Ho KY, Tordoir JH, van Engelshoven JM. Peripheral arterial disease: comparison of color duplex US and contrast-enhanced MR angiography for diagnosis. Radiology. 2005 May;235(2):699-708. doi: 10.1148/radiol.2352040089.
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Klein WM, van der Graaf Y, Seegers J, Spithoven JH, Buskens E, van Baal JG, Buth J, Moll FL, Overtoom TT, van Sambeek MR, Mali WP. Dutch iliac stent trial: long-term results in patients randomized for primary or selective stent placement. Radiology. 2006 Feb;238(2):734-44. doi: 10.1148/radiol.2382041053. Epub 2005 Dec 21.
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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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BACKGROUND
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BACKGROUND
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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S6052
Identifier Type: -
Identifier Source: org_study_id
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