protocolSection identificationModule nctId: NCT06365502, orgStudyIdInfo id: KY2023-156, briefTitle: Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque (RESTORE Trial), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2030-12, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Harbin Medical University, class: OTHER, collaborators name: Shanghai Shenqi Medical Technology Co., Ltd, descriptionModule briefSummary: The objective of this multicenter, prospective, open-label, controlled, randomized trial is to demonstrate the superiority of drug-coated balloon (DCB) treatment on non-flow limited vulnerable plaque as compared to guideline-directed medical therapy (GDMT) in improving clinical cardiovascular outcomes in patients with acute coronary syndrome., conditionsModule conditions: Acute Coronary Syndrome (ACS), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1860, type: ESTIMATED, armsInterventionsModule interventions name: Drug-coated balloon, interventions name: Guideline-directed medical treatment, outcomesModule primaryOutcomes measure: Target lesion failure (TLF), secondaryOutcomes measure: Target lesion failure (TLF), secondaryOutcomes measure: Target lesion failure (TLF), secondaryOutcomes measure: Target lesion failure (TLF), secondaryOutcomes measure: Major cardiac adverse event (MACE), secondaryOutcomes measure: Major cardiac adverse event (MACE), secondaryOutcomes measure: Major cardiac adverse event (MACE), secondaryOutcomes measure: Major cardiac adverse event (MACE), secondaryOutcomes measure: All-cause death, secondaryOutcomes measure: All-cause death, secondaryOutcomes measure: All-cause death, secondaryOutcomes measure: All-cause death, secondaryOutcomes measure: Cardiac death and target lesion MI, secondaryOutcomes measure: Cardiac death and target lesion MI, secondaryOutcomes measure: Cardiac death and target lesion MI, secondaryOutcomes measure: Cardiac death and target lesion MI, secondaryOutcomes measure: Cardiac death, secondaryOutcomes measure: Cardiac death, secondaryOutcomes measure: Cardiac death, secondaryOutcomes measure: Cardiac death, secondaryOutcomes measure: Target lesion myocardial infarction, secondaryOutcomes measure: Target lesion myocardial infarction, secondaryOutcomes measure: Target lesion myocardial infarction, secondaryOutcomes measure: Target lesion myocardial infarction, secondaryOutcomes measure: Periprocedural myocardial infarction, secondaryOutcomes measure: Periprocedural myocardial infarction, secondaryOutcomes measure: Periprocedural myocardial infarction, secondaryOutcomes measure: Periprocedural myocardial infarction, secondaryOutcomes measure: Periprocedural and non-periprocedural myocardial infarction, secondaryOutcomes measure: Periprocedural and non-periprocedural myocardial infarction, secondaryOutcomes measure: Periprocedural and non-periprocedural myocardial infarction, secondaryOutcomes measure: Periprocedural and non-periprocedural myocardial infarction, secondaryOutcomes measure: Target vessel failure (TVF), secondaryOutcomes measure: Target vessel failure (TVF), secondaryOutcomes measure: Target vessel failure (TVF), secondaryOutcomes measure: Target vessel failure (TVF), secondaryOutcomes measure: Minimal lumen area after DCB treatment, secondaryOutcomes measure: Plaque burden after DCB treatment, secondaryOutcomes measure: FCT after DCB treatment, secondaryOutcomes measure: Lipid arc after DCB treatment, secondaryOutcomes measure: FCT <75 μm after DCB treatment, secondaryOutcomes measure: PB >65% after DCB treatment, secondaryOutcomes measure: PB >70% after DCB treatment, secondaryOutcomes measure: MLA <3.5 mm^2 after DCB treatment, secondaryOutcomes measure: Maximal lipid arc >180° after DCB treatment, secondaryOutcomes measure: Cardiac biomarkers: GDF-15, interleukin-6, interleukin-1β and ceramide etc., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Affiliated Beijing Luhe Hospital of Capital Medical University, city: Beijin, state: Beijing, zip: 101149, country: China, contacts name: Guangyao zhai, role: CONTACT, contacts name: Guangyao zhai, role: PRINCIPAL_INVESTIGATOR, locations facility: Affiliated Hospital of Zunyi Medical University, city: Zunyi, state: Guizhou, zip: 563000, country: China, geoPoint lat: 27.68667, lon: 106.90722, locations facility: Daqing Oilfield General Hospital, city: Daqing, state: Heilongjiang, zip: 150000, country: China, geoPoint lat: 46.58333, lon: 125.0, locations facility: The Second Affiliated Hospital of Harbin Medical University, city: Harbin, state: Heilongjiang, zip: 150000, country: China, contacts name: Haibo Jia, PhD, role: CONTACT, contacts name: Bo Yu, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Haibo Jia, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 45.75, lon: 126.65, locations facility: The First Affiliated Hospital of Jiamusi University, city: Jiamusi, state: Heilongjiang, zip: 150000, country: China, contacts name: Guangyuan Yang, role: CONTACT, contacts name: Guangyuan Yang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.79927, lon: 130.31633, locations facility: Mudanjiang Cardiovascular Hospital, city: Mudanjiang, state: Heilongjiang, zip: 150000, country: China, contacts name: Kai Liu, role: CONTACT, contacts name: Kai Liu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.58333, lon: 129.6, locations facility: Fuwai Central China Cardiovascular Hospital, city: Zhengzhou, state: Henan, zip: 450000, country: China, geoPoint lat: 34.75778, lon: 113.64861, locations facility: The First Affiliated Hospital of Zhengzhou University, city: Zhengzhou, state: Henan, zip: 450000, country: China, contacts name: Chunguang Qiu, role: CONTACT, contacts name: Chunguang Qiu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Tongji Hospital Tongji Medical College of HUST, city: Wuhan, state: Hubei, zip: 430022, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: The Third Second Hospital of Jilin University, city: Changchun, state: Jilin, zip: 132000, country: China, contacts name: Bin Liu, role: CONTACT, contacts name: Bin Liu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.88, lon: 125.32278, locations facility: Dalian Municipal Central Hospital, city: Dalian, state: Liaoning, zip: 116000, country: China, contacts name: Xiaoqun Zheng, role: CONTACT, contacts name: Xiaoqun Zheng, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.91222, lon: 121.60222, locations facility: The First Affiliated Hospital of Dalian Medical University, city: Dalian, state: Liaoning, zip: 116000, country: China, contacts name: Bo Zhang, role: CONTACT, contacts name: Bo Zhang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.91222, lon: 121.60222, locations facility: The People's Hospital of Liaoning Province, city: Shengyang, state: Liaoning, zip: 132000, country: China, locations facility: The Affiliated Hospital of Neimenggu Medical University, city: Hohhot, state: Neimenggu, zip: 011500, country: China, contacts name: Fengying Chen, role: CONTACT, contacts name: Fengying Chen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.81056, lon: 111.65222, locations facility: Shandong Provincial Hospital, city: Jinan, state: Shandong, zip: 250000, country: China, contacts name: Haitao Yuan, role: CONTACT, contacts name: Haitao Yuan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Affiliated Hospital of Jining Medical University, city: Jining, state: Shandong, zip: 250000, country: China, contacts name: Lijun Gan, role: CONTACT, contacts name: Lijun Gan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.405, lon: 116.58139, locations facility: The Affiliated Hospital of Qingdao University, city: Qingdao, state: Shandong, zip: 250000, country: China, contacts name: Peng Li, role: CONTACT, contacts name: Peng Li, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.06488, lon: 120.38042, locations facility: Yantai Yuhuangding Hospital, city: Yantai, state: Shandong, zip: 250000, country: China, contacts name: Lin Zhong, role: CONTACT, contacts name: Lin Zhong, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.47649, lon: 121.44081, hasResults: False