Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2026-01-11 @ 3:12 PM
Study NCT ID:
NCT01816412
Status:
COMPLETED
Last Update Posted:
2016-09-28
First Post:
2013-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LEVANT Japan Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018232', 'term': 'Rhabdomyosarcoma, Alveolar'}], 'ancestors': [{'id': 'D012208', 'term': 'Rhabdomyosarcoma'}, {'id': 'D009217', 'term': 'Myosarcoma'}, {'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012509', 'term': 'Sarcoma'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-27', 'studyFirstSubmitDate': '2013-03-19', 'studyFirstSubmitQcDate': '2013-03-21', 'lastUpdatePostDateStruct': {'date': '2016-09-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of freedom from all-cause peri-operative (≤30 day) death and freedom at 6 months from the following: index limb amputation (above or below the ankle), index limb re-intervention, and index-limb-related death.', 'timeFrame': '6 months', 'description': 'Primary Patency'}], 'secondaryOutcomes': [{'measure': 'Safety', 'timeFrame': '1, 3, 6, 12 and 24 months', 'description': 'Composite of freedom from all-cause peri-operative (≤30 day) death and freedom at 6 months from the following: index limb amputation (above or below the ankle), index limb re-intervention, and index-limb-related death.'}, {'measure': 'Efficacy', 'timeFrame': '1, 3, 6, 12 and 24 months', 'description': 'Primary Patency of the target lesion at 6 months. Primary Patency is defined as the absence of target lesion restenosis (defined by DUS peak systolic velocity ratio (PSVR) ≥2.5) and freedom from target lesion revascularization (TLR).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Arms', 'Experimental', 'Drug Coated Angioplasty Balloon', 'Active Comparator', 'Standard angioplasty balloon'], 'conditions': ['Femoral Arterial Stenosis', 'Stenosis of Popliteal Arteries', 'Femoral Artery Occlusion', 'Occlusion of Popliteal Arteries']}, 'referencesModule': {'references': [{'pmid': '31575518', 'type': 'DERIVED', 'citation': 'Ouriel K, Adelman MA, Rosenfield K, Scheinert D, Brodmann M, Pena C, Geraghty P, Lee A, White R, Clair DG. Safety of Paclitaxel-Coated Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease. JACC Cardiovasc Interv. 2019 Dec 23;12(24):2515-2524. doi: 10.1016/j.jcin.2019.08.025. Epub 2019 Sep 28.'}]}, 'descriptionModule': {'briefSummary': 'To demonstrate the safety and efficacy of MD02-LDCB for treatment of stenosis or occlusion of the femoral and popliteal arteries in the Japanese population.', 'detailedDescription': 'The study will enroll patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery and a patent outflow artery to the foot. After successful protocol-defined pre-dilatation, subjects that are determined not to require stenting based on defined angiographic criteria are randomized 2:1 to treatment with either MD02-LDCB (test arm) or standard PTA catheter (control arm) using similar techniques. Subjects that do not meet post-predilatation lesion criteria are excluded (and treated per standard practice) and followed for safety for 30 days. Randomized subjects will have ultrasound follow-up through 2 years and are consented for up to 2 years clinical follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or non-pregnant female ≥20 years of age;\n* Rutherford Clinical Category 2-4;\n* Length ≤15 cm;\n* ≥70% stenosis\n* Lesion location starts ≥1 cm below the common femoral bifurcation and terminates distally ≤2 cm below the tibial plateau AND ≥1 cm above the origin of the TP trunk;\n* A patent inflow artery as confirmed by angiography\n* At least one patent native outflow artery to the ankle\n\nExclusion Criteria:\n\n* Life expectancy of \\< 2 years;\n* History of hemorrhagic stroke within 3 months;\n* Previous or planned surgical or interventional procedure within 2 weeks before or within 30 days after the index procedure;\n* History of MI, thrombolysis or angina within 2 weeks of enrollment;\n* Renal failure or chronic kidney disease\n* Severe calcification that renders the lesion un-dilatable'}, 'identificationModule': {'nctId': 'NCT01816412', 'briefTitle': 'LEVANT Japan Clinical Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'C. R. Bard'}, 'officialTitle': 'A Prospective, Multicenter, Single Blind, Randomized, Controlled Japanese Population Trial Comparing MD02-LDCB Versus Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries', 'orgStudyIdInfo': {'id': 'MD02-LDCB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LDCB', 'description': 'Paclitaxel Coated Balloon', 'interventionNames': ['Device: MD02-LDCB Paclitaxel coated balloon catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PTA', 'description': 'Standard Uncoated Balloon Angioplasty Catheter PTA Catheter', 'interventionNames': ['Procedure: Standard Uncoated Balloon Angioplasty Catheter']}], 'interventions': [{'name': 'MD02-LDCB Paclitaxel coated balloon catheter', 'type': 'DEVICE', 'armGroupLabels': ['LDCB']}, {'name': 'Standard Uncoated Balloon Angioplasty Catheter', 'type': 'PROCEDURE', 'otherNames': ['PTA Catheter'], 'armGroupLabels': ['PTA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3-1-69', 'city': 'Amagasaki-shi', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Kansai Rosai Hospital.'}], 'overallOfficials': [{'name': 'Hiroyoshi Yokoi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kokura Memorial Hospital Cardiovascular Internal Medicine'}, {'name': 'Osamu lida', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kansai Rosai Hospital Cardiovascular Internal Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'C. R. Bard', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medicon, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}