Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-02-25 @ 4:48 PM
Study NCT ID:
NCT03910166
Status:
COMPLETED
Last Update Posted:
2024-08-01
First Post:
2019-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AcoArt VI / Vertebral Artery Ostium Stenosis in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D002546', 'term': 'Ischemic Attack, Transient'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002545', 'term': 'Brain Ischemia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-30', 'studyFirstSubmitDate': '2019-04-09', 'studyFirstSubmitQcDate': '2019-04-09', 'lastUpdatePostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of target lesion restenosis', 'timeFrame': '12Months', 'description': 'Target Lesion Restenosis（diameter stenosis ≥50%） under DSA at 12 Months or diamater stenosis ≥50% under DSA before Target Lesion Revascularization within 12 Months'}, {'measure': 'Rate of device success', 'timeFrame': 'during the operation', 'description': 'DEB group: DEB catheter can reach the target lesions, expand as expected (not broken),and withdraw successfully. BES group: the stenosis rate of proximal outflow less than 50% with intervention and no ischemia or hemorrhage occurred.'}], 'secondaryOutcomes': [{'measure': 'Rate of device success', 'timeFrame': 'during the operation', 'description': 'DEB group: DEB catheter can reach the target lesions, expand as expected (not broken),and withdraw successfully. BES group: the stenosis rate of proximal outflow less than 50% with intervention and no ischemia or hemorrhage occurred.'}, {'measure': 'Incidence of hemorrhagic stroke and posterior circulation ischemic stroke', 'timeFrame': '12 Months', 'description': 'incidence of hemorrhagic stroke and posterior circulation ischemic stroke within 12 months'}, {'measure': 'Incidence of transient ischemic attack of posterior circulation', 'timeFrame': '12 Months', 'description': 'incidence of transient ischemic attack of posterior circulation within 12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['drug eluting balloon catheter', 'stenting'], 'conditions': ['Ischemic Stroke', 'Transient Ischemic Attack']}, 'referencesModule': {'references': [{'pmid': '41067866', 'type': 'DERIVED', 'citation': 'Luo J, Jiang C, Wang H, Peng R, Wang T, Kuai D, Liang G, Wang F, Wang S, Xu C, Chen W, Deng J, Hu X, Wan S, Li B, Yin B, Du Y, Cheng G, Wan J, Chen X, Wang Y, Jiao L; DCB-VAOS Trial Investigators. Effect of drug-coated balloon in patients with severe vertebral artery origin stenosis: A multicenter randomized controlled trial. Int J Stroke. 2025 Oct 9:17474930251377055. doi: 10.1177/17474930251377055. Online ahead of print.'}, {'pmid': '33584491', 'type': 'DERIVED', 'citation': 'Wang Y, Ma Y, Gao P, Chen Y, Yang B, Feng Y, Jiao L. Paclitaxel Coated Balloon vs. Bare Metal Stent for Endovascular Treatment of Symptomatic Vertebral Artery Origin Stenosis Patients: Protocol for a Randomized Controlled Trial. Front Neurol. 2021 Jan 18;11:579238. doi: 10.3389/fneur.2020.579238. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether DEB is not inferior to common bare metal stent using under in long-term vessel patency and inhibiting restenosis in Vertebral Artery Ostium Stenosis', 'detailedDescription': 'Vertebral Artery Origin Stenting is an established alternative to open surgical bypass for the treatment of Vertebral Artery Ostium Stenosis .\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', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged between 18 and 80 years old\n* symptomatic VAO stenosis refractory to AMM (aggressive medical management)\n* etiology of VAOS was atherosclerosis\n* the diameter of the normal segment of the artery beyond the stenosis between 3mm and 5mm\n* Target lesion has stenosis ≥ 70% evidenced by angiography\n* Score on the modified Rankin scale ≤ 3\n* NIHSS≤ 6\n* Patients have signed informed consent\n\nExclusion Criteria:\n\n* In-stent restenosis in vertebral artery\n* Severe calcified lesion or residual stenosis ≥30% after predilatation or flow-limiting dissection\n* Tortuous or variable vessels\n* distal serial stenosis or distal vascular dysplasia of the stenosis segment\n* Non-atherosclerotic arterial stenosis\n* Non-vertebral artery stenosis caused TIA or stroke\n* intracranial stent implantation within 12 months\n* Intracranial hemorrhage occurred within 3 months\n* Obvious thrombosis in brain vessel, or have received thrombolytic therapy 24 hours before procedure\n* Active bleeding or coagulation disorders\n* Serious liver/kidney damage, not suitable for routine surgical treatment\n* Myocardial infarction or extensive cerebral infarction occurred within 2 weeks\n* Uncontrolled high blood pressure\n* Complicated intracranial tumor, cerebral arteriovenous malformation, or intracranial aneurysm\n* Potential sources of cardiogenic thrombosis, such as mitral stenosis, atrial septal defect, aorta or mitral valve replacement, left atrial myxoma, etc\n* Life expectancy shorter than 1 years\n* Patients whit cognitive impairment or mental disorders\n* Known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc\n* Pregnant and lactating women\n* Patients who have participated in other clinical trials during the same period that lead to researchers who believe that patients may not be able to follow the trial program'}, 'identificationModule': {'nctId': 'NCT03910166', 'briefTitle': 'AcoArt VI / Vertebral Artery Ostium Stenosis in 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 of Vertebral Artery Ostium Stenosis', 'orgStudyIdInfo': {'id': 'Acotec-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DCB group', 'description': 'use DEB catheter(trade name:Orchid/Dhalia) to treat the stenosis or occlusion in Vertebral Artery Ostium Stenosis of experimental arm', 'interventionNames': ['Procedure: drug-coated balloon catheter（Orchid, Acotec）']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BMS group', 'description': 'use Intracranial artery stent system(trade name:Apollo) to treat stenosis or occlusion in Vertebral Artery Ostium Stenosis of control group', 'interventionNames': ['Procedure: Intracranial artery stent system（APOLLO）']}], 'interventions': [{'name': 'drug-coated balloon catheter（Orchid, Acotec）', 'type': 'PROCEDURE', 'description': 'After predilation, using drug-coated balloon catheter to cover the whole treated segment', 'armGroupLabels': ['DCB group']}, {'name': 'Intracranial artery stent system（APOLLO）', 'type': 'PROCEDURE', 'description': 'stent assisted angioplasty', 'armGroupLabels': ['BMS group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Xuanwu hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Liqun Jiao, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Xuanwu Hospital, Beijing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acotec Scientific Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}