Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-25 @ 4:23 PM
Study NCT ID:
NCT03504657
Status:
UNKNOWN
Last Update Posted:
2018-05-04
First Post:
2018-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Drug-coated Balloon Angioplasty for Patients With Symptomatic Vertebral Artery Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014715', 'term': 'Vertebrobasilar Insufficiency'}], 'ancestors': [{'id': 'D002545', 'term': 'Brain Ischemia'}, {'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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-02', 'studyFirstSubmitDate': '2018-04-12', 'studyFirstSubmitQcDate': '2018-04-12', 'lastUpdatePostDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Serious adverse events', 'timeFrame': '30 days'}], 'primaryOutcomes': [{'measure': 'Restenosis', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'The composite of vascular death, myocardial infarction, or any stroke', 'timeFrame': 'within 30 days after the start of treatment'}, {'measure': 'The composite of vascular death, myocardial infarction, or any stroke', 'timeFrame': 'within 12 months after the start of treatment'}, {'measure': 'Death resulting from any cause', 'timeFrame': '12 months'}, {'measure': 'Stroke in the supply territory of the symptomatic vertebral artery', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vertebral Artery Stenosis', 'Drug-coated balloon angioplasty', 'Stenting'], 'conditions': ['Vertebral Artery Stenosis']}, 'descriptionModule': {'briefSummary': 'Posterior circulation stroke accounts for 20% of ischemic stroke. A quarter occurs in patients with stenosis in the vertebral and/or basilar arteries. Vertebral artery stenosis can be treated with stenting. However, in-stent restenosis rate have been reported as high as more than 30%, which may reduce the effect of stent therapy. Drug-coated balloon has shown good results in controlling neointimal hyperplasia in the femoral and popliteal arteries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Patients presenting with posterior circulation transient ischemic attack or nondisabling stroke in the previous 6 months\n* Vertebral artery origin stenosis resulting from presumed atheromatous disease with stenosis ≥50%\n* Lesion length of the stenosis \\>5mm.\n* Angioplasty can be performed within two weeks after randomization\n* Female subjects of childbearing potential have a negative pregnancy test.\n* Signed informed consent prior to entering study\n\nExclusion Criteria:\n\n* Potential cause of TIA or minor stroke other than stenosis in a vertebral artery (e.g. atrial fibrillation)\n* Life expectancy shorter than 2 years\n* Vertebral artery stenosis caused by dissection\n* Vertebral stenting felt to be technically impracticable\n* Previous stenting in randomized artery\n* Pre-morbid modified Rankin scale score of greater than 3\n* Currently participating or previously participated in any investigational drug or device study within 6 months.'}, 'identificationModule': {'nctId': 'NCT03504657', 'briefTitle': 'Drug-coated Balloon Angioplasty for Patients With Symptomatic Vertebral Artery Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Zhengzhou University'}, 'officialTitle': 'Drug-coated Balloon Angioplasty for Patients With Symptomatic Vertebral Artery Stenosis', 'orgStudyIdInfo': {'id': 'FAHZU-2018-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drug-coated balloon angioplasty', 'interventionNames': ['Device: Drug-coated balloon angioplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'stenting angioplasty', 'interventionNames': ['Device: stenting angioplasty']}], 'interventions': [{'name': 'Drug-coated balloon angioplasty', 'type': 'DEVICE', 'description': 'Angioplasty with a drug-coated angioplasty', 'armGroupLabels': ['Drug-coated balloon angioplasty']}, {'name': 'stenting angioplasty', 'type': 'DEVICE', 'description': 'Angioplasty with a stenting', 'armGroupLabels': ['stenting angioplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yajun Lian, MD', 'role': 'CONTACT', 'email': 'lianyajun369@yahoo.com', 'phone': '008613838367143'}], 'facility': 'The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Nanyang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Changming Wen, MD', 'role': 'CONTACT'}], 'facility': 'Nanyang City Center Hospital', 'geoPoint': {'lat': 32.99472, 'lon': 112.53278}}], 'centralContacts': [{'name': 'Chuanjie Wu, MD', 'role': 'CONTACT', 'email': 'wuchuanjie8557@163.com', 'phone': '008618911366882'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Chuanjie Wu', 'investigatorAffiliation': 'The First Affiliated Hospital of Zhengzhou University'}}}}