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