Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-02 @ 3:43 AM
Study NCT ID:
NCT03201432
Status:
COMPLETED
Last Update Posted:
2017-06-28
First Post:
2016-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Eluting Stents Versus Bare Metal Stents for Treatment of Symptomatic Extracranial Vertebral Artery Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D014715', 'term': 'Vertebrobasilar Insufficiency'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054855', 'term': 'Drug-Eluting Stents'}], 'ancestors': [{'id': 'D015607', 'term': 'Stents'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No Masking'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-25', 'studyFirstSubmitDate': '2016-03-04', 'studyFirstSubmitQcDate': '2017-06-25', 'lastUpdatePostDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stent restenosis rate 6 months after stenting', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Stent restenosis rate 3 months after stenting', 'timeFrame': '3 months'}, {'measure': 'Stent restenosis rate 12 months after stenting', 'timeFrame': '12 months', 'description': 'measured by ultrasound'}, {'measure': 'The incidence of cardiovascular events (stroke, TIA, Miocardial infarction and death) 6 months after stenting', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vertebral Artery Stenosis', 'Ischemic Stroke', 'Stent'], 'conditions': ['Ischemic Stroke', 'Vertebral Artery Stenosis']}, 'descriptionModule': {'briefSummary': 'Stroke is one of the important causes of disability and death in the world, in which more than half were ischemic strokes. About 1/4 of the ischemic stroke occurred in the vertebral basilar artery system, especially when in the presence of extracranial proximal vertebral artery stenosis. Vertebral artery stenting is a minimally invasive method for the reconstruction of vertebral artery stenosis and the early clinical studies showed that it was feasible, safe and effective, but the high rate of restenosis has become a bottleneck restricting its development. Previous systematic review had suggested that the drug eluting stent might reduce the incidence of restenosis of vertebral artery. However, prospective randomized controlled trials comparing the efficacy of bare metal stents and drug eluting stents on the prevention of restenosis remains absent.', 'detailedDescription': '60 patients were randomly assigned into DES and BES group to compare the safety and efficacy in the treatment of symptomatic extracranial vertebral artery stenosis with drug eluting stents (YINYI) and bare metal stents (Express SD), especially the stent restenosis rate after 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Symptomatic posterior circulation ischemia（Vertebral basilar artery system TIA or non-disabling ischemic stroke）result from the stenosis in the extracranial proximal vertebral artery stenosis.\n* Atherosclerotic extracranial proximal vertebral artery stenosis demonstrated by angiography(any of the following): 1) bilateral vertebral artery stenosis ≥70%, or vertebral artery stenosis ≥70% concomitant occlusion of contralateral vertebral artery; 2) superior lateral vertebral artery stenosis ≥70%; 3) non-superior lateral vertebral artery stenosis ≥50%, but the vertebral artery was directly extended to the posterior inferior cerebellar artery on this side and symptoms were related to insufficiency of the ipsilateral posterior inferior cerebellar artery.\n\nExclusion Criteria:\n\n* 1\\) lesions characteristics (such as diffuse lesions) which was not suitable for interventional treatment, or unstable condition that cannot tolerate the interventional therapy;\n* 2\\) vertebral artery stenosis caused by non atherosclerosis disease: Takayasu arteritis or other diseases;\n* 3\\) severe stroke within 3 months;\n* 4\\) contraindicated using contrast agents: such as chronic renal insufficiency or had serious contrast agents allergy history;\n* 5\\) malignant tumor;\n* 6\\) with Alzheimer's disease or mental illness previously or currently ;\n* 7\\) patients or family members refuse the operation."}, 'identificationModule': {'nctId': 'NCT03201432', 'briefTitle': 'Drug Eluting Stents Versus Bare Metal Stents for Treatment of Symptomatic Extracranial Vertebral Artery Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}, 'officialTitle': 'A Randomized Trial for Treatment of Symptomatic Extracranial Vertebral Artery Stenosis: Drug Eluting Stents Versus Bare Metal Stents', 'orgStudyIdInfo': {'id': '2014-ZX15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Bare metal stent (BES) group', 'description': 'Percutaneous vertebral artery stenting using bare metal stents (Boston Scientific：Express SD) in patients randomized to BES group', 'interventionNames': ['Device: Bare metal stent (BES)']}, {'type': 'EXPERIMENTAL', 'label': 'Drug eluting stent (DES) group', 'description': 'Percutaneous vertebral artery stenting using drug eluting stents (Liaoning Biomedical Materials R\\&D Center Co., Ltd. ：YINYI) in patients randomized to DES group', 'interventionNames': ['Device: Drug eluting stent (DES)']}], 'interventions': [{'name': 'Drug eluting stent (DES)', 'type': 'DEVICE', 'otherNames': ['YINYI (Liaoning Biomedical Materials R&D Center Co., Ltd.)'], 'description': 'Polymer-free paclitaxel eluting stents', 'armGroupLabels': ['Drug eluting stent (DES) group']}, {'name': 'Bare metal stent (BES)', 'type': 'DEVICE', 'otherNames': ['Express SD (Bosten Scientific)'], 'description': 'Bare metal stent', 'armGroupLabels': ['Bare metal stent (BES) group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Xiongjing Jiang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiongjing Jiang', 'class': 'OTHER'}, 'collaborators': [{'name': 'Yinyi(Liaoning) Biotech Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xiongjing Jiang', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}}}}