Nctid:
NCT06614972
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000002537", "term"=>"Intracranial Arteriosclerosis"}, {"id"=>"D000050197", "term"=>"Atherosclerosis"}], "ancestors"=>[{"id"=>"D000001161", "term"=>"Arteriosclerosis"}, {"id"=>"D000001157", "term"=>"Arterial Occlusive Diseases"}, {"id"=>"D000014652", "term"=>"Vascular Diseases"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D000020765", "term"=>"Intracranial Arterial Diseases"}, {"id"=>"D000002561", "term"=>"Cerebrovascular Disorders"}, {"id"=>"D000001927", "term"=>"Brain Diseases"}, {"id"=>"D000002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}], "browseLeaves"=>[{"id"=>"M6475", "name"=>"Constriction, Pathologic", "relevance"=>"LOW"}, {"id"=>"M26188", "name"=>"Atherosclerosis", "asFound"=>"Atherosclerosis", "relevance"=>"HIGH"}, {"id"=>"M22306", "name"=>"Stroke", "relevance"=>"LOW"}, {"id"=>"M10543", "name"=>"Ischemia", "relevance"=>"LOW"}, {"id"=>"M2400", "name"=>"Ischemic Stroke", "relevance"=>"LOW"}, {"id"=>"M4469", "name"=>"Arteriosclerosis", "relevance"=>"LOW"}, {"id"=>"M5786", "name"=>"Intracranial Arteriosclerosis", "asFound"=>"Intracranial Atherosclerosis", "relevance"=>"HIGH"}, {"id"=>"M4465", "name"=>"Arterial Occlusive Diseases", "relevance"=>"LOW"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}, {"id"=>"M22521", "name"=>"Intracranial Arterial Diseases", "relevance"=>"LOW"}, {"id"=>"M5810", "name"=>"Cerebrovascular Disorders", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M21960", "name"=>"Sirolimus", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>520}, "targetDuration"=>"5 Years", "patientRegistry"=>true}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-09-30", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2030-09-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-23", "studyFirstSubmitDate"=>"2024-09-20", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-09-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"In-stent restenosis(ISR) rate", "timeFrame"=>"2-5 years after implantation", "description"=>"The ISR is defined as \\>50% stenosis within or immediately adjacent (within 5 mm) of the implanted stent and \\>20% absolute luminal loss on angiographic experiment."}, {"measure"=>"Any cerebral events", "timeFrame"=>"2-5 years after implantation", "description"=>"Cerebral events defined as transient ischemic attack (TIA), ischemic stroke, thrombus and death in the territory of the qualifying artery."}], "primaryOutcomes"=>[{"measure"=>"Any stroke or death within 30 days of implantation or any revascularization procedure OR an ischemic stroke in the territory of the symptomatic intracranial artery between 31 day to 1 year.", "timeFrame"=>"12 months after implantation", "description"=>"Primary endpoints are composite event of (1) any stroke or death within 30 days after enrollment, (2) any stroke or death within 30 days after revascularization procedure of the qualifying lesion during follow-up, and (3) ischemic stroke in the territory of the qualifying artery from 31 days to 1 year."}], "secondaryOutcomes"=>[{"measure"=>"Any cerebral events within 1 year", "timeFrame"=>"12 months after implantation", "description"=>"Cerebral events defined as transient ischemic attack (TIA), ischemic stroke, thrombus and death in the territory of the qualifying artery"}, {"measure"=>"Periprocedural events", "timeFrame"=>"within 30 days after implantation", "description"=>"Periprocedural events defined as transient ischemic attack (TIA), ischemic stroke and all-cause death."}, {"measure"=>"In-stent restenosis(ISR) rate", "timeFrame"=>"12 months after implantation", "description"=>"The ISR is defined as \\>50% stenosis within or immediately adjacent (within 5 mm) of the implanted stent and \\>20% absolute luminal loss on angiographic experiment."}, {"measure"=>"Technique success rate", "timeFrame"=>"During the procedure", "description"=>"Technique success was defined as successful arrival of stent to the lesion and subsequent release of the stent delivery system with a residual stenosis of \\<30%."}, {"measure"=>"Functional outcome measured by modified Rankin Scale and NIH stroke scale (NIHSS) score", "timeFrame"=>"Every year after implantation during 5 years", "description"=>"Modified Rankin Scale (mRS) score and NIHSS score(if need) at every year after implantation during 5 years. The range of modified Rankin Scale was from 0 to 6. 0-No symptoms;1-No significant disability;2-Slight disability;3-Moderate disability;4-Moderately severe disability;5-Severe disability;6 -Dead. A higher score indicates a worse outcome. NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. The minimum score is 1 and the maximum score is 20. A higher score indicates a worse outcome."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Intracranial Atherosclerosis Stroke", "Drug-eluting stent"], "conditions"=>["Atheroscleroses, Cerebral", "Intracranial Atherosclerosis", "Ischemia Stroke"]}, "referencesModule"=>{"references"=>[{"pmid"=>"30659967", "type"=>"BACKGROUND", "citation"=>"Li G, Wang N, Li X, Ma N, Liu T, Sun Y, Liu P, Miao Z, Zhang Y. Balloon-Mounted versus Self-Expanding Stent Outcomes in Symptomatic Middle Cerebral Artery Stenosis Combined with Poor Collaterals in China: A Multicenter Registry Study. World Neurosurg. 2019 Apr;124:e675-e681. doi: 10.1016/j.wneu.2018.12.189. Epub 2019 Jan 16."}, {"pmid"=>"31030623", "type"=>"BACKGROUND", "citation"=>"Zhang Y, Rajah GB, Liu P, Sun Y, Liu T, Li X, Miao Z, Li G. Balloon-mounted versus self-expanding stents for symptomatic intracranial vertebrobasilar artery stenosis combined with poor collaterals. Neurol Res. 2019 Aug;41(8):704-713. doi: 10.1080/01616412.2019.1610837. Epub 2019 Apr 28."}, {"pmid"=>"35549530", "type"=>"BACKGROUND", "citation"=>"Abdollahifard S, Yousefi O, Kamran H, Mowla A. Balloon-mounting stent for intracranial arterial stenosis: A comprehensive and comparative systematic review and meta-analysis. Interv Neuroradiol. 2023 Aug;29(4):466-480. doi: 10.1177/15910199221100620. Epub 2022 May 12."}, {"pmid"=>"32972537", "type"=>"BACKGROUND", "citation"=>"Bartstra JW, van den Beukel TC, Van Hecke W, Mali WPTM, Spiering W, Koek HL, Hendrikse J, de Jong PA, den Harder AM. Intracranial Arterial Calcification: Prevalence, Risk Factors, and Consequences: JACC Review Topic of the Week. J Am Coll Cardiol. 2020 Sep 29;76(13):1595-1604. doi: 10.1016/j.jacc.2020.07.056."}, {"pmid"=>"30294474", "type"=>"BACKGROUND", "citation"=>"Ma N, Zhang Y, Shuai J, Jiang C, Zhu Q, Chen K, Liu L, Li B, Shi X, Gao L, Liu Y, Wang F, Li Y, Liu T, Zheng H, Mo D, Gao F, Wang Y, Wang Y, Feng L, Miao Z. Stenting for symptomatic intracranial arterial stenosis in China: 1-year outcome of a multicentre registry study. Stroke Vasc Neurol. 2018 May 7;3(3):176-184. doi: 10.1136/svn-2017-000137. eCollection 2018 Sep."}]}, "descriptionModule"=>{"briefSummary"=>"To study the clinical outcomes after implantation of balloon-expandable drug-eluting stents in patients with symptomatic intracranial atherosclerotic stenosis in prevention of composite event of any stroke and death within 30 days and ischemic stroke in the territories of the responsible artery from 31 days to 1-year.", "detailedDescription"=>"This study is a prospective, multi-center, real world, registry study. This study aimed to evaluate the effectiveness of balloon-expandable drug-eluting stents in treating stenosis in the C2-C7 segments of the internal carotid artery and V4 artery which with high prevalence of calcified plaques in ICAD."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"Patients with symptomatic intracranial arteries stenosis within 3 months include vertebral artery V4 segment or internal carotid artery C2-C7 segment, and the degree of diseased arterial stenosis is between 70%\\~99%.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. According to clinical and angiographic evidence, symptomatic intracranial arteries stenosis within 3 months include vertebral artery V4 segment or internal carotid artery C2-C7 segment, and the degree of diseased arterial stenosis is between 70%\\~99% (WASID method).\n3. Patients have more than 1 episode of symptoms including stroke or transient ischemia attack (TIA) after intensive medical treatment (including antiplatelet therapy, antihypertensive, hypoglycemic and lipid-lowering treatments).\n4. Patients have at least 1 risk factor for intracranial atherosclerosis, including previous or existing hypertension, hyperlipidemia, diabetes mellitus, smoking, alcohol consumption, obesity, underlying heart disease, family history of atherosclerotic vascular disease, hyperhomocysteinemia and so on.\n5. Baseline mRS score ≤3.\n6. Patient or guardian signs informed consent.\n\nExclusion Criteria:\n\n1. Patients who cannot receive dual antiplatelet therapy due to existing diseases or with server coagulation dysfunction, uncontrolled serious infections, serious systemic diseases, uncontrollable hypertension and other conditions are not suitable for surgery.\n2. Patients with aneurysm that cannot be treated in advance or at the same time or are not suitable for surgery.\n3. Gastrointestinal disease with active bleeding.\n4. Myocardial infarction or massive cerebral infarction within 2 weeks.\n5. Patients with known severe allergies or contraindications to heparin, rapamycin, anesthesia and contrast media.\n6. Life expectancy \\<12 months.\n7. According to the judgement of the investigator, other situations that are not suitable for enrollment."}, "identificationModule"=>{"nctId"=>"NCT06614972", "briefTitle"=>"Balloon-expandable DES for ICAS Registry Study (BDES-ICAS Registry)", "organization"=>{"class"=>"OTHER", "fullName"=>"RenJi Hospital"}, "officialTitle"=>"Clinical Outcome of Balloon-Expandable Drug-Eluting Stenting For Patients With Intracranial Atherosclerotic Stenosis: a Prospective, Multicenter, Real-World Registry Study", "orgStudyIdInfo"=>{"id"=>"LY2024-188-B"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"balloon-expandable drug-eluting stent", "description"=>"Patients were treated with balloon-expandable drug-eluting stent.", "interventionNames"=>["Device: Balloon-expandable drug-eluting stent"]}], "interventions"=>[{"name"=>"Balloon-expandable drug-eluting stent", "type"=>"DEVICE", "description"=>"Balloon-expandable drug-eluting stent (BDES) is the device comprises of a balloon expandable sirolimus eluting stent and a delivery catheter that features a rapid exchange catheter design with a semi-compliant balloon located at its distal end.", "armGroupLabels"=>["balloon-expandable drug-eluting stent"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Yameng Sun", "role"=>"CONTACT", "email"=>"Frank_sym@163.com", "phone"=>"+86-13621603083"}, {"name"=>"Wenhua Sun", "role"=>"CONTACT", "email"=>"tennis_sun@126.com", "phone"=>"+86-15000029306"}], "overallOfficials"=>[{"name"=>"Jieqing Wan", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"RenJi Hospital"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED", "description"=>"Haven't decided share IPD to other researchers."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"RenJi Hospital", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
