Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-20 @ 12:00 AM
Study NCT ID:
NCT02717104
Status:
COMPLETED
Last Update Posted:
2020-07-17
First Post:
2016-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Korean Post-market Registry Assessing the Clinical Use and Safety of the Lutonix DCB in Femoropopliteal Arteries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 249}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-16', 'studyFirstSubmitDate': '2016-03-16', 'studyFirstSubmitQcDate': '2016-03-18', 'lastUpdatePostDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom from Target Lesion Revascularization', 'timeFrame': '12 months'}, {'measure': 'Freedom from Target Vessel and Target Lesion Revascularization', 'timeFrame': '30 days'}, {'measure': 'Freedom from Major Amputation and Major Reintervention of index limb', 'timeFrame': '30 days'}, {'measure': 'Freedom from device- and procedure-related death', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['femoropopliteal'], 'conditions': ['Peripheral Artery Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of the registry is to assess the clinical use and safety of the LUTONIX Drug Coated Balloon Catheter in a heterogeneous patient population in real world clinical practice.', 'detailedDescription': 'The registry will enroll patients with claudication or critical limb ischemia due to stenotic lesions in femoropopliteal arteries. All subjects meeting protocol criteria will be treated with the LUTONIX Drug Coated Balloon Catheter for approved indications according to the current Instructions for Use (IFU) and followed clinically for 2 years.\n\nTotal enrollment will be approximately 250 subjects at up to 18 sites. Subject follow-up will occur at 1, 6, 12 and 24 months. The primary efficacy endpoint is freedom from target lesion revascularization at 12 months.\n\nThe primary safety endpoint is freedom at 30 days from the composite endpoint of target vessel revascularization and target lesion revascularization, major amputation and major reintervention of index limb, and device- and procedure-related death.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'General patient pool of participating hospitals or clinics', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥19 years of age\n* Rutherford Clinical Category ≥4\n* Patient or Legally Authorized Representative is willing to provide informed consent and comply with the required follow-up\n* Stenotic or obstructive vascular lesions in femoropopliteal artery(s)\n* Lesion(s) can be treated with available LUTONIX Drug Coated Balloon Catheter device size matrix per current IFU\n* At least one patent native outflow artery to the ankle free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of outflow disease is NOT permitted; treatment of in-flow disease is permitted prior to treatment with the LUTONIX Drug Coated PTA Dilatation Catheter)\n\nExclusion Criteria:\n\n* Patient is currently participating in an active phase of another investigational drug or device study\n* Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast\n* Known inadequate distal outflow or planned future (within 30 days) treatment of vascular disease distal to the target lesion'}, 'identificationModule': {'nctId': 'NCT02717104', 'briefTitle': 'Korean Post-market Registry Assessing the Clinical Use and Safety of the Lutonix DCB in Femoropopliteal Arteries', 'organization': {'class': 'INDUSTRY', 'fullName': 'C. R. Bard'}, 'officialTitle': 'A Prospective, Multicenter, Single Arm, Post-Market Registry Assessing the Clinical Use and Safety of the LUTONIX Drug Coated Balloon Catheter in Femoropopliteal Arteries', 'orgStudyIdInfo': {'id': 'KORL15100'}}, 'contactsLocationsModule': {'locations': [{'zip': '431-796', 'city': 'Anyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Hallym University Sacred Heart Hospital', 'geoPoint': {'lat': 37.3925, 'lon': 126.92694}}, {'city': 'Bucheon-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Soonchunjyang University Hospital', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'zip': '412-270', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Myongji Hospital', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'city': 'Seoul', 'state': 'Jongno-gu', 'country': 'South Korea', 'facility': 'Kangbuk Samsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Busan Veterans Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Inje University Busan Park Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '700-712', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Keimyung University Dongsan Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '705-703', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'YeungNam University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '301-721', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '501-757', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '400-711', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '110-799', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '137-040', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Seoul St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '143-729', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Konkuk University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '443-380', 'city': 'Suwon', 'country': 'South Korea', 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'Jae Kyu Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chonnam National University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'C. R. Bard', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}