Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-04-09 @ 6:59 AM
Study NCT ID:
NCT01850056
Status:
COMPLETED
Last Update Posted:
2018-07-12
First Post:
2013-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AcoArt Ⅰ / SFA 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-11', 'studyFirstSubmitDate': '2013-04-27', 'studyFirstSubmitQcDate': '2013-05-07', 'lastUpdatePostDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Late Lumen Loss', 'timeFrame': '6 months', 'description': 'measure difference of the MLD(minimal lumen diameter) at 0 time and 6 months'}], 'secondaryOutcomes': [{'measure': 'Minimal lumen diameter (MLD)', 'timeFrame': '6 months', 'description': 'measure minimal lumen diameter (MLD) of target lesion'}, {'measure': 'Restenosis rate of target vessel', 'timeFrame': '6 months, 12 months, 18 months, 24months', 'description': 'stenosis over 50% is defined as restenosis'}, {'measure': 'target lesion revascularization', 'timeFrame': '6 months, 12 months, 18 months, 24 months', 'description': 'target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion'}, {'measure': 'change in Rutherford stage', 'timeFrame': '6 months, 12 months, 18 months, 24 months', 'description': 'based the following definition of Rutherford stage, evaluate the stage of patient. Then compare the stage of patient just after procedure and 6 months after treatment\n\nStage clinical symptom\n\n0 asymptomatic\n\n1. mild claudication\n2. moderate claudication\n3. severe claudication\n4. ischemic rest pain\n5. minor tissue loss\n6. ulceration or gangrene'}, {'measure': 'change in ankle brachial index(ABI)', 'timeFrame': '6 months', 'description': 'change in ankle brachial index(ABI) compared to pretreatment'}, {'measure': 'major amputation', 'timeFrame': '6 months, 12 months, 18 months, 24 months', 'description': 'major amputation at the index limb(major amputation is defined as an amputation above the foot)'}, {'measure': 'Death', 'timeFrame': '12 months, 18 months, 24 months', 'description': 'death of any cause'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['drug eluting balloon catheter'], 'conditions': ['Peripheral Artery Disease']}, 'referencesModule': {'references': [{'pmid': '34385840', 'type': 'DERIVED', 'citation': 'Ren H, Liu J, Zhang J, Zhuang B, Fu W, Wu D, Wang F, Zhao Y, Guo P, Bi W, Wang S, Guo W. Five-Year Outcomes of Post-Drug-Coated Balloon Angioplasty Dissection in Complex Femoropopliteal Artery Disease. Int J Gen Med. 2021 Aug 5;14:4197-4207. doi: 10.2147/IJGM.S316916. eCollection 2021.'}, {'pmid': '32903168', 'type': 'DERIVED', 'citation': 'Sun G, Liu J, Jia S, Zhang J, Zhuang B, Jia X, Fu W, Wu D, Wang F, Zhao Y, Guo P, Bi W, Wang S, Guo W; AcoArt I Trial Investigators. Comparison of drug-coated balloon angioplasty versus uncoated balloon angioplasty in treatment of total occlusions with severe femoropopliteal lesions: An additional analysis from the AcoArt I study. Vascular. 2021 Jun;29(3):340-349. doi: 10.1177/1708538120953663. Epub 2020 Sep 9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether DEB is more effective than common PTA balloon in long-term vessel patency and inhibiting restenosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', '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 40cm\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* 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* target lesion can't be cross by the guide wire\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 2 years)\n* patients unable or unwilling to participate this trial"}, 'identificationModule': {'nctId': 'NCT01850056', 'briefTitle': 'AcoArt Ⅰ / SFA China', 'organization': {'class': 'INDUSTRY', 'fullName': 'Acotec Scientific Co., Ltd'}, 'officialTitle': 'Prospective, Multi-center and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Drug-eluting Balloon in PTA Procedure (AcoArt I Study)', 'orgStudyIdInfo': {'id': 'acotec-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'drug eluting balloon catheter', 'description': 'use drug eluting balloon catheter to inflate the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery', 'interventionNames': ['Device: drug eluting balloon catheter (trade name: Orchid)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'common balloon catheter(uncoated drug)', 'description': 'use common balloon catheter to inflate stenosis or occlusion in SFA and/or popliteal artery', 'interventionNames': ['Device: common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral)']}], 'interventions': [{'name': 'drug eluting balloon catheter (trade name: Orchid)', 'type': 'DEVICE', 'otherNames': ['drug eluting dilation catheter'], 'armGroupLabels': ['drug eluting balloon catheter']}, {'name': 'common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral)', 'type': 'DEVICE', 'otherNames': ['common PTA catheter'], 'armGroupLabels': ['common balloon catheter(uncoated drug)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100091', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Xiyuan Hospital CACMS', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'The First Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'The First Affiliated Hospital of Fujian Medical University', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '050000', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'The second Hospital Of Hebei University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Dalian', 'state': 'Liaoning', 'country': 'China', 'facility': 'The First Affiliated Hospital, Dalian Medical University', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': "The People's Hospital of Liaoning Province", 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Zhongshan Hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Renji Hospital ShangHai Jiaotong University School Of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acotec Scientific Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}