Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-01-04 @ 3:42 AM
Study NCT ID:
NCT03311360
Status:
COMPLETED
Last Update Posted:
2021-08-03
First Post:
2017-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Coated Balloon Versus Stenting in Patients With Symptomatic Vertebral Artery Stenosis：an Observational Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-31', 'studyFirstSubmitDate': '2017-10-09', 'studyFirstSubmitQcDate': '2017-10-11', 'lastUpdatePostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of vascular death,non-fatal myocardial and non-fatal stroke in 12 months', 'timeFrame': '12 months', 'description': 'vascular death,non-fatal myocardial and non-fatal stroke diagnosed by specialist physician'}], 'secondaryOutcomes': [{'measure': 'lumen loss at 6 months', 'timeFrame': '6 months', 'description': 'lumen loss measured by doppler untrasound'}, {'measure': 'lumen loss at 12 months', 'timeFrame': '12 months', 'description': 'lumen loss measured by doppler untrasound'}, {'measure': 'restenosis at 6 months', 'timeFrame': '6 months', 'description': 'restenosis was assessed by doppler untrasound'}, {'measure': 'restenosis at 12 months', 'timeFrame': '12 months', 'description': 'restenosis was assessed by doppler untrasound'}, {'measure': 'traget lesion revascularizition at 12 months', 'timeFrame': '12 months', 'description': 'traget lesion revascularizition including envascular intervention and Surgery'}, {'measure': 'Incidence of safety events including vascular death,non-fatal myocardial infarction, or non-fatal stroke in 30 days', 'timeFrame': '30 days', 'description': 'safety events including vascular death,non-fatal myocardial infarction, or non-fatal stroke diagnosed by investigators within 30 days after start of the treatment'}, {'measure': 'stent fracture rate at 12 months', 'timeFrame': '12 months', 'description': 'stent fracture was assessed by DSA'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vertebral artery origin stenosis', 'drug-coated balloon', 'stenting', 'medical treatment'], 'conditions': ['Vertebral Artery Origin Stenosis']}, 'descriptionModule': {'briefSummary': 'There are two arms in our trial, DCB group, BMS group.The investigators are going to investigate the safety and efficacy of all groups at 6 months and 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients meet all of the inclusion criteria and none of the excusion criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. aged between 18 and 80 years old;\n2. TIA or non-disabling ischaemic stroke of the posterior circulation;\n3. symptoms occurred in the 14 days and could not be relieved after 2 months of regular medication\n4. stenosis of the vertebral artery of 50% or greater, diagnosed by both CT angiography or angiography;\n5. NIHSS≤ 6;\n6. score on the modified Rankin scale ≤ 3.\n\nExclusion Criteria:\n\n1. Active bleeding or coagulation disorders or severe renal/liver impairment\n2. allergy to iodinated contrast agent or related medicines;\n3. acute stroke in 3 weeks\n4. more than 1 stenosis at the target vessel or Distal vascular dysplasia (diameter≤3mm)\n5. a potential cause of stenosis other than atherosclerosis\n6. Severe stenosis was found in the anterior circulation artery(\\>70%)\n7. intracranial hemorrhage or hemorrhagic stroke, intracranial tumor, cerebral arteriovenous malformation, or intracranial aneurysm in 30 days;\n8. ISR patients;\n9. Severe calcification lesion；\n10. obvious thrombosis in vessel;\n11. pregnancy;\n12. a potential cause of TIA or minor stroke other than stenosis in a vertebral artery.'}, 'identificationModule': {'nctId': 'NCT03311360', 'briefTitle': 'Drug Coated Balloon Versus Stenting in Patients With Symptomatic Vertebral Artery Stenosis：an Observational Clinical Study', 'organization': {'class': 'OTHER', 'fullName': 'Chinese Society of Interventional Radiology'}, 'officialTitle': 'Chinese Society of Interventional Radiology', 'orgStudyIdInfo': {'id': 'CSIR01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'drug-coated balloon', 'description': 'patients with vertebral artery origin stenosis treated with drug-coated balloons', 'interventionNames': ['Device: drug-coated balloon']}, {'label': 'bare metal stent', 'description': 'patients with vertebral artery origin stenosis treated with bare metal stent', 'interventionNames': ['Device: bare metal stent']}], 'interventions': [{'name': 'drug-coated balloon', 'type': 'DEVICE', 'description': 'Orchid and Dahlia DCB', 'armGroupLabels': ['drug-coated balloon']}, {'name': 'bare metal stent', 'type': 'DEVICE', 'description': 'any type of bare metal stent', 'armGroupLabels': ['bare metal stent']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Anzhen hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'The rockets army general hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Dalian', 'country': 'China', 'facility': 'The first affiliated hospital of Dalian medical university', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'city': 'Harbin', 'country': 'China', 'facility': 'The first affiliated hospital of Harbin medical university', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'city': 'Jilin', 'country': 'China', 'facility': 'The first hospital of Jilin university', 'geoPoint': {'lat': 43.84652, 'lon': 126.5608}}, {'city': 'Shenyang', 'country': 'China', 'facility': 'Shengjing Hosptal of china medical university', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Zhengzhou', 'country': 'China', 'facility': 'Henan provincial peoples hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Zhengzhou', 'country': 'China', 'facility': 'The first hospital of zhengzhou university', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Zhengzhou', 'country': 'China', 'facility': 'Zhengzhou center hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Society of Interventional Radiology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}