Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-04-15 @ 9:34 PM
Study NCT ID:
NCT02197559
Status:
COMPLETED
Last Update Posted:
2016-10-24
First Post:
2014-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bare -Metal Stents and Drug -Eluting Stents in the Treatment of Patients With Vertebral Artery Ostium Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-21', 'studyFirstSubmitDate': '2014-07-21', 'studyFirstSubmitQcDate': '2014-07-21', 'lastUpdatePostDateStruct': {'date': '2016-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Late loss in lumen diameter in follow-up ≥50%', 'timeFrame': '1 year', 'description': 'Late loss in lumen diameter in follow-up ≥50%'}, {'measure': 'Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs', 'timeFrame': '30 days', 'description': 'Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs'}, {'measure': 'Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs', 'timeFrame': '12 months', 'description': 'Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs'}], 'secondaryOutcomes': [{'measure': 'brain, gastrointestinal and urinary system bleeding in 12 months follow-up', 'timeFrame': '12 months', 'description': 'brain, gastrointestinal and urinary system bleeding in 12 months follow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ischemic Stroke, restenosis,bare-metal stents, drug -eluting stents'], 'conditions': ['Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'The study hypothesizes that Drug -eluting stents are more effective in preventing restenosis than Bare-metal stents after Vertebral Artery Ostium stenting', 'detailedDescription': 'The vertebral artery ostium stenosis was one of the higher risk of the ischemia stroke in China. In the mean time ,more and more people accept revascularization. There are no prospective studies for comparison of prevention of restenosis after Drug -eluting stents and Bare-metal stents until now.\n\nThe main aim of this study is to observe the following details:\n\n1. Late loss in lumen diameter in follow-up ≥50%\n2. Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs\n3. Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs\n\nSecondary endpoint:\n\nbrain, gastrointestinal and urinary system bleeding in 12 months follow-up'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Symptomatic status: as evidenced by TIA or non-severe stroke within the past 12 months attributed to 70% to 99% stenosis of vertebral artery ostium are eligible. Degree of stenosis: \\>70% and \\<99%; stenosis may be diagnosed by TCD, MRA, or CTA to qualify for angiogram performed as part of the study protocol, but must be confirmed by catheter angiography for enrollment in the trial. All the patients should be performed with PTAS beyond a duration of 3 weeks from the latest ischemic symptom onset. No fresh infarctions identified on MRI (indicated as high signals on DWI series) upon enrollment.Patient is willing and able to return for all follow-up visits required by the protocol Patient understands the purpose and requirements of the study, can make him/herself understood, and has signed informed consent.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- symptomatic posterior circulation ischemia including monor stroke (mRS ≤2) or TIA result from the stenosis in the vertebral artery ostium.\n\n70% to 99% stenosis of vertebral artery ostium.\n\nExclusion Criteria:\n\n* etiology of stenotic lesions not atherosclerosis patients had undergone previos interventions on the vertebral artery ostium ipsilateral severe stenotic lesions in subclavian artery involved as well as vertebral artery ostium'}, 'identificationModule': {'nctId': 'NCT02197559', 'briefTitle': 'Bare -Metal Stents and Drug -Eluting Stents in the Treatment of Patients With Vertebral Artery Ostium Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': 'A Prospectie Cohort Study of Bare -Metal Stents and Drug -Eluting Stents in the Treatment of Patients With Vertebral Artery Ostium Stenosis', 'orgStudyIdInfo': {'id': 'BEST-VAOS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BMS group, DES group', 'description': 'All the participants in this group will be performed with bare-metal stents or drug -eluting stents', 'interventionNames': ['Procedure: DES group', 'Procedure: BMS group']}], 'interventions': [{'name': 'DES group', 'type': 'PROCEDURE', 'otherNames': ['Drug -eluting stents group'], 'description': 'all the participants in this group will be performed with drug -eluting stents', 'armGroupLabels': ['BMS group, DES group']}, {'name': 'BMS group', 'type': 'PROCEDURE', 'otherNames': ['Bare-metal stents group'], 'description': 'all the participants in this group will be performed with bare-metal stents', 'armGroupLabels': ['BMS group, DES group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'country': 'China', 'facility': 'Department of neurosurgery, Xuanwu hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Feng Ling, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xuanwu Hospital, Capital University of Medical Sciences, Beijing, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}