Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-01-10 @ 9:41 AM
Study NCT ID:
NCT03267056
Status:
COMPLETED
Last Update Posted:
2020-08-19
First Post:
2017-08-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AcoArt IV / SFA in China:Drug-eluting Balloon for SFA Angioplasty Evaluation in China
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': 120}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-18', 'studyFirstSubmitDate': '2017-08-24', 'studyFirstSubmitQcDate': '2017-08-28', 'lastUpdatePostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary patency of target lesion.', 'timeFrame': '12 months', 'description': 'The primary efficacy end point was primary patency at 12 months following the index procedure, defined as freedom from clinically driven target lesion revascularization and restenosis as determined by a duplex ultrasonography-derived peak systolic velocity ratio of\n\n≤2.4'}], 'secondaryOutcomes': [{'measure': 'target lesion revascularization,target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion', 'timeFrame': '6 months, 12 months', 'description': 'target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion'}, {'measure': 'improvment in Rutherford stage', 'timeFrame': '6 months, 12 months', 'description': 'improvementin Rutherford stage is defined as an upward shift of at least 1 category on Rutherford classification as compared to baseline'}, {'measure': 'change in ankle brachial index(ABI)', 'timeFrame': '12 months', 'description': 'change in ankle brachial index(ABI) compared to baseline'}, {'measure': 'Device success during the operation', 'timeFrame': 'during the operation', 'description': 'Device success is defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['drug-coated balloon'], 'conditions': ['Peripheral Artery Disease']}, 'descriptionModule': {'briefSummary': 'The registry is a prospective, multicenter, single arm post-market real-world registry in China assessing the clinical use, safety and outcomes of the Orchid 035 DCB Catheter in the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA).', 'detailedDescription': 'PTA is an established alternative to open surgical bypass for the treatment of infrainginual disease of critical limb ischemia.\n\nDEBs are designed to promote arterial patency by reducing neointimal proliferation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with a more than 70% stenosis at femoral and/or popliteal artery meet all the inclusion and excluison criteria', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 18 and 80 years\n* Patients with peripheral artery disease (PAD), with Rutherford classification between 2 and 5\n* an occlusion or a minimum grade of stenosisPrimary over 70% in the superficial femoral artery an /or the popliteal artery\n* Total length of treat lesion(s)is less or equal to 20cm\n* signed Patient informed consent form\n\nExclusion Criteria:\n\n* plasma Cr level greater than 150 umol/L in patients\n* patients with acute thrombosis requiring lysis or thrombectomy\n* 2 or more than 2 stenosis lesions in traget vessel\n* patient with a lysis or an lower limb intervention as a therapy within the last 6 weeks\n* patient requiring intervention in both lower limbs at the same time\n* have \\>30% residual stenosis or blood-limited dissection after predilation\n* distal outflow through less than one lower leg vessel\n* known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc.\n* patients participating in another clinical trials with interfere with this trial in the past 3 months\n* pregnancy and lactating woman\n* untreatable bleeding diatheses\n* other diseases, such as cancer, liver disease, or cardiac insufficiency, which may lead to protocol violations or markedly shorten a patients's life expectancy(less than 1 years)\n* patients unable or unwilling to participate this trial"}, 'identificationModule': {'nctId': 'NCT03267056', 'briefTitle': 'AcoArt IV / SFA in China:Drug-eluting Balloon for SFA Angioplasty Evaluation in China', 'organization': {'class': 'INDUSTRY', 'fullName': 'Acotec Scientific Co., Ltd'}, 'officialTitle': 'Real-World Registry Assessing the Clinical Use of the Orchid Drug Coated Balloon Catheter', 'orgStudyIdInfo': {'id': 'Acotec-04'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DCB arm', 'description': 'drug eluting balloon catheter', 'interventionNames': ['Device: drug eluting balloon catheter (trade name: Orchid)']}], 'interventions': [{'name': 'drug eluting balloon catheter (trade name: Orchid)', 'type': 'DEVICE', 'description': 'use drug eluting balloon catheter(trade name: Orchid) to inflate the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery', 'armGroupLabels': ['DCB arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'The second hospital of hebei medical university', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Harbin', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'The second affiliated hospital of Harbin medical university', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Wuhan central hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Jiangsu Province Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Dalian', 'state': 'Liaoning', 'country': 'China', 'facility': 'The First Affiliated Hospital of Dalian Medical University', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'Shengjing Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin First Center Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Nanjing', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The First Affiliated Hospital of Zhejiang University'}], 'overallOfficials': [{'name': 'Wei Guo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese PLA General Hospital'}, {'name': 'Yinghua Zou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University First Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acotec Scientific Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}