[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621753":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":50,"collaborators":54,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":25,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":25,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":77,"overallStatus":87,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Shenyang Northern Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intravascular ultrasound (IVUS)-guided implantation of BioFreedom™ drug-coated coronary stent system","EXPERIMENTAL","1 month of dual antiplatelet therapy (DAPT: aspirin 100mg\u002Fday + clopidogrel 75mg\u002Fday or ticagrelor 90mg twice daily) followed by 11 months of single antiplatelet therapy (SAPT: clopidogrel 75mg\u002Fday or ticagrelor 90mg twice daily)",[13],"Device: IVUS-guided BioFreedomTM Drug-Coated Stent Implantation + 1-Month DAPT Followed by 11-Month P2Y12 Inhibitor Monotherapy",{"label":15,"type":6,"description":16,"interventionNames":17},"Angiography-guided implantation of other drug-eluting stents (DES)","12 months of conventional dual antiplatelet therapy (DAPT: aspirin 100mg\u002Fday + clopidogrel 75mg\u002Fday or ticagrelor 90mg twice daily)",[18],"Device: Angiography-guided Conventional Drug-Eluting Stent Implantation + 12-Month Dual Antiplatelet Therapy (Aspirin + P2Y12 Inhibitor)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","IVUS-guided BioFreedomTM Drug-Coated Stent Implantation + 1-Month DAPT Followed by 11-Month P2Y12 Inhibitor Monotherapy","Intravascular ultrasound (IVUS)-guided implantation of BioFreedom™ polymer-free drug-coated stent, followed by 1-month dual antiplatelet therapy (DAPT: aspirin + P2Y12 inhibitor) and 11-month P2Y12 inhibitor monotherapy for ACS patients with high bleeding and intermediate-to-high ischemic risk.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Angiography-guided Conventional Drug-Eluting Stent Implantation + 12-Month Dual Antiplatelet Therapy (Aspirin + P2Y12 Inhibitor)","Coronary angiography-guided implantation of conventional drug-eluting stent (DES), with 12-month standard DAPT (aspirin + P2Y12 inhibitor) for the same patient population.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Haiwei Liu, Professor","CONTACT","+8613309883005","ifoliuhw@sina.com",[37],{"facility":38,"status":25,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":25},"General Hospital of Northern Theater Command","Shenyang","Liaoning","110000","China","CN",{"type":45,"coordinates":46},"Point",[47,48],123.43278,41.79222,{"lat":48,"lon":47},{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Han Yaling","Director, clinical professor",[55],{"name":56,"class":6},"Chinese Academy of Medical Sciences, Fuwai Hospital","100621753","safety-and-efficacy-of-de-escalation-dual-antiplatelet-therapy-after-biofreedom-stenting-in-acs-patients-with-moderate-to-high-ischemic-and-high-bleeding-risk-100621753",false,"NCT07374718","Safety and Efficacy of De-escalation Dual Antiplatelet Therapy After BioFreedom™ Stenting in ACS Patients With Moderate-to-high Ischemic and High Bleeding Risk","Optimization and Verification of Quality Control Indicators for Coronary Revascularization Based on Antiplatelet Therapy: Safety and Efficacy of De-escalation Dual Antiplatelet Therapy in Moderate-to-high Ischemic Risk and High Bleeding Risk ACS Patients After BioFreedom™ Drug-Coated Coronary Stenting","Inclusion Criteria:\n\n* Aged ≥ 18 years old\n* ACS patients with high bleeding risk (meeting the ARC-HBR criteria)\n* Moderate-to-high ischemic risk (OPT-CAD score ≥ 90)\n* Predicted by the investigator to be able to tolerate 12 months of DAPT\n* Voluntarily participate and sign the informed consent form, and be willing to receive the designated follow-up of this trial at specific time points\n* Coronary artery lesions are primary and in-situ coronary artery lesions\n* Target lesion diameter stenosis ≥ 70% or ≥ 50% (visual estimation) accompanied by evidence of myocardial ischemia\n\nExclusion Criteria:\n\n* Patients with known allergy or contraindication to P2Y12 inhibitors, aspirin, or contrast agents\n* Patients planning to undergo surgical intervention within 12 months\n* Left Ventricular Ejection Fraction (LVEF) \\\u003C 35%\n* Patients with contraindications to PCI\n* Patients with a history of substance abuse (alcohol, cocaine, heroin, etc.), or with an expected life expectancy of less than 1 year\n* Subjects with poor compliance or judged by the investigator to be unsuitable for participating in the study\n* Female patients who are planning to be pregnant or are pregnant\u002Flactating, and male patients planning to impregnate\n* Chronic total occlusion lesions\n* Lesions involving the left main coronary artery\n* Severe calcified and tortuous lesions","ALL","18 Years",{"count":67,"type":68},468,"ESTIMATED","INTERVENTIONAL",[71],"NA","Patients with acute coronary syndrome (ACS) who have both high ischemic risk and high bleeding risk represent a challenging population following percutaneous coronary intervention (PCI), as prolonged dual antiplatelet therapy (DAPT) may reduce ischemic events but increases bleeding complications.This prospective, multicenter, randomized controlled study evaluates the safety and effectiveness of an optimized PCI and antiplatelet therapy strategy in ACS patients with moderate-to-high ischemic risk and high bleeding risk. Eligible patients will be randomized in a 1:1 ratio to either an experimental strategy consisting of intravascular ultrasound-guided implantation of a polymer-free drug-coated stent followed by one month of DAPT and subsequent single antiplatelet therapy, or a control strategy consisting of angiography-guided implantation of contemporary drug-eluting stents followed by standard 12-month DAPT.The primary hypothesis is that the experimental strategy will reduce the incidence of net adverse clinical events, defined as a composite of ischemic and bleeding outcomes, compared with conventional PCI and prolonged DAPT. Participants will be followed for 12 months after the index procedure.",[74,75,76],"Acute Coronary Syndrome (ACS)","High Bleeding Risk(HBR)","Coronary Artery Disease (CAD)",[78,74,79,80,81,82,83,84,85,86],"Dual Antiplatelet Therapy (DAPT)","High Bleeding Risk (HBR)","Percutaneous Coronary Intervention (PCI)","Quality Control Indicators","Coronary Revascularization","Real-World Research","Bleeding Events","Ischemic Events","Post-PCI Prognosis","NOT_YET_RECRUITING","2026-01-20",{"date":90,"type":91},"2026-01-29","ACTUAL",{"date":93,"type":68},"2026-03-01",{"date":95,"type":68},"2029-06-30",{"name":5,"class":6},1]