[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610689":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":52,"collaborators":11,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":11,"eligibilityCriteria":59,"healthyVolunteers":56,"sex":60,"minAge":61,"maxAge":11,"enrollmentInfo":62,"targetDuration":11,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":11,"overallStatus":38,"whyStopped":11,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"China National Center for Cardiovascular Diseases","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BioFreedom™ Drug-Coated Coronary Stent Intervention Group","EXPERIMENTAL",null,[13],"Device: BioFreedom™",{"label":15,"type":16,"description":11,"interventionNames":17},"Xience Drug-Eluting Coronary Stent System Intervention Group","ACTIVE_COMPARATOR",[18],"Device: Xience",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DEVICE","BioFreedom™","BioFreedom™ Drug-Coated Coronary Stent Intervention",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Xience","Xience Drug-Eluting Coronary Stent System Intervention",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Yongjian Wu","CONTACT","13701387189","fuwaiwyj@163.com",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Fuwai hospital, CAMS&PUMC","RECRUITING","Beijing","Beijing Municipality","100037","China","CN",{"type":45,"coordinates":46},"Point",[47,48],116.39723,39.9075,{"lat":48,"lon":47},[51],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},{"type":53,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100610689","a-study-evaluating-the-vascular-healing-and-neointimal-transformation-at-1-month-after-implantation-of-biofreedom-drug-coated-stents-and-the-xience-drug-eluting-stent-system-in-patients-with-acute-coronary-syndrome-and-high-bleeding-risk-using-optical-coherence-tomography-100610689",false,"NCT07230847","A Study Evaluating the Vascular Healing and Neointimal Transformation at 1 Month After Implantation of BioFreedom™ Drug-coated Stents and the Xience Drug-eluting Stent System in Patients With Acute Coronary Syndrome and High Bleeding Risk Using Optical Coherence Tomography","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Male or non-pregnant female\n3. Acute coronary syndrome (ACS) patients requiring percutaneous coronary intervention (PCI)\n4. No contraindications for coronary artery bypass grafting (CABG)\n5. High bleeding risk (HBR) patients per ARC-HBR definition (meeting ≥1 major or 2 minor criteria):\n\n   Major Criteria:\n   * Expected long-term oral anticoagulation\n   * Severe\u002Fend-stage chronic kidney disease (eGFR \\\u003C30 mL\u002Fmin)\n   * Moderate\u002Fsevere anemia (Hb \\\u003C110 g\u002FL)\n   * Spontaneous bleeding requiring hospitalization\u002Ftransfusion within 6 months (or recurrent)\n   * Chronic bleeding diathesis\n   * Moderate\u002Fsevere thrombocytopenia pre-PCI (platelet count \\\u003C100×10⁹\u002FL)\n   * Liver cirrhosis with portal hypertension\n   * Active malignancy in past 12 months (excluding non-melanoma skin cancer; defined as diagnosis\u002Ftreatment within 12 months)\n   * History of spontaneous intracranial hemorrhage\n   * Traumatic intracranial hemorrhage within 12 months\n   * Known cerebral arteriovenous malformation\n   * Moderate\u002Fsevere ischemic stroke within 6 months\n   * Major surgery\u002Fsevere trauma within 30 days pre-PCI\n   * Planned non-deferrable major surgery during dual antiplatelet therapy\n\n   Minor Criteria:\n   * Age ≥75 years\n   * Moderate chronic kidney disease (eGFR:30\\~59 ml\u002Fmin)\n   * Mild anemia (male: Hb=110\\~129 g\u002FL; female: Hb=110\\~119 g\u002FL)\n   * Spontaneous bleeding requiring hospitalization\u002Ftransfusion within 6-12 months pre-PCI\n   * Chronic NSAID\u002Fsteroid use post-PCI\n   * Ischemic stroke \\>6 months pre-PCI\n6. Capable of understanding trial objectives and providing informed consent\n\nAngiographic Inclusion Criteria:\n\n1. Target lesion must be primary native coronary artery lesion\n2. Target lesion with ≥70% diameter stenosis (visual estimate), or 50-70% diameter stenosis (visual estimate) with ischemic evidence\n3. ≥1 non-target lesion requiring intervention\n4. Non-target lesions eligible for elective treatment within 1 month\n\nExclusion Criteria:\n\nGeneral Exclusion Criteria:\n\n1. Presence of ≥1 evidence of heart failure including:\n\n   * NYHA Class III or higher, or\n   * Killip classification ≥ Grade 2, or\n   * Left ventricular ejection fraction (LVEF) ≤30% within 30 days pre-procedure (by echocardiography or intraoperative ventriculography)\n2. Cardiogenic shock patients\n3. Known allergies to: Aspirin \u002F clopidogrel \u002F ticagrelor \u002F heparin, Contrast agents\u002Fdrugs used in drug-eluting stents or contraindications to aspirin\u002F clopidogrel \u002F ticagrelor\n4. Life expectancy \\\u003C12 months or factors potentially compromising clinical follow-up\n5. Participation in other drug\u002Fmedical device trials prior to enrollment without reaching primary endpoint timelines\n6. History of substance abuse (alcohol\u002Fcocaine\u002Fheroin, etc.)\n7. Severe arrhythmias (e.g., high-risk ventricular premature contractions\u002F ventricular tachycardia)\n8. Other medical conditions deemed unsuitable by investigators\n\nAngiographic Exclusion Criteria:\n\n1. Left main coronary artery disease\n2. Bypass graft lesions\n3. Evidence of extensive thrombus in target vessel","ALL","18 Years",{"count":63,"type":64},60,"ESTIMATED","INTERVENTIONAL",[67],"NA","BioFreedom™ is the world's first polymer-free drug-coated stent (DCS), utilizing a proprietary microstructured surface technology. Its abluminal microporous surface directly carries BA9™ (a sirolimus derivative) with high lipophilicity. This design mitigates inflammatory responses while promoting early vascular healing and reducing thrombotic risk. Extensive clinical evidence has validated BioFreedom™'s superior performance in high-bleeding-risk (HBR) populations. However, comprehensive assessments of neointimal coverage and quantitative neointimal transformation post-implantation remain insufficient. With advancements in ultra-high-resolution optical coherence tomography (OCT), detailed evaluation of coronary stent healing has become feasible. This study will employ OCT to comparatively assess vascular healing patterns-including neointimal transformation and strut coverage-in ACS patients with HBR receiving either the commercially available BioFreedom™ DCS or Xience drug-eluting stent system. The findings will provide multidimensional insights into the devices' post-implantation efficacy and safety profiles.",[70,71],"Coronary Heart Disease","Acute Coronary Syndrome","2026-03-31",{"date":74,"type":75},"2026-04-06","ACTUAL",{"date":77,"type":75},"2025-12-10",{"date":79,"type":64},"2027-03-31",{"name":5,"class":6},1]