[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"silent-ischemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:silent-ischemia":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100627155","safety-and-effectiveness-of-the-crystalline-sirolimus-eluting-device-in-patients-with-coronary-artery-disease-100627155",false,"NCT07444957","Safety and Effectiveness of the Crystalline Sirolimus-Eluting Device in Patients With Coronary Artery Disease","Safety and Effectiveness of the Crystalline Sirolimus-Eluting Device (SeQuent® Sirolimus-Coated Balloon) in Patients With Coronary Artery Disease: A Prospective Observational Study","SECuRE","Inclusion Criteria:\n\n* All patients must provide written informed consent.\n* Patients aged ≥18 years with coronary artery disease in whom, at the operator's discretion, treatment of a coronary stenosis in a native vessel (either de novo lesion or in-stent restenosis) or in a coronary bypass graft using the cSCB is indicated, in accordance with routine clinical practice.\n* All treated lesions\u002Fsegments (single or tandem) must receive cSCB therapy covering at least 3 mm beyond both edges of the lesion or pre-dilated segment to avoid geographic miss.\n* In patients with multivessel coronary artery disease, all non-target vessels will be treated according to operator discretion: a) If more than one vessel is treated with the investigational device (SeQuent® SCB), all vessels will be documented and analyzed separately. b) Only one lesion per vessel will be included unless lesions are separated by ≥20 mm. c) Only one lesion per vessel will be included. d) If more than one lesion in the target vessel requires treatment, all lesions treated with a device different from the investigational procedure or with a device other than the investigational device (SeQuent® SCB) must be separated from the target lesion by ≥20 mm or considered as a single treated lesion according to this study protocol.\n\nExclusion Criteria:\n\n* Explicit refusal by the patient to participate in the study.\n* Known intolerance to sirolimus or to any component of the investigational device.\n* Contraindication to any antiplatelet therapy.\n* Life expectancy less than 12 months.\n* Indication for surgical coronary revascularization.\n* Pregnancy or breastfeeding.\n* Clinical characteristics considered unsuitable for drug-coated balloon use at the operator's discretion, including: a) Hemorrhagic diathesis or other conditions such as gastrointestinal ulceration or cerebrovascular disorders restricting the use of antiplatelet therapy. b) Cardiogenic shock. c) Patients with left ventricular ejection fraction \\\u003C30% without the use of a ventricular assist device during PCI.\n\nAngiographic exclusion criteria\n\n* Reference vessel diameter \\\u003C2.00 mm or \\>4.0 mm.\n* Treatment of the left main coronary artery.\n* Lesions not amenable to PCI or other interventional techniques.\n* Coronary artery spasm in the absence of significant stenosis.\n* Target lesion not suitable for drug-coated balloon-only PCI at the operator's discretion, including: a) Aorto-ostial lesions. b) Lesions with significant persistent residual thrombotic content visible in the vessel despite thromboaspiration. c) Treatment shortly after myocardial infarction with evidence of thrombus or impaired coronary flow.","ALL","18 Years",{"count":20,"type":21},1118,"ESTIMATED","OBSERVATIONAL","This prospective, multicenter, post-market observational study aims to evaluate the safety and effectiveness of the crystalline sirolimus-coated balloon (SeQuent® Sirolimus-Coated Balloon) for the treatment of coronary artery disease in routine clinical practice. Consecutive, unselected adult patients undergoing percutaneous coronary intervention for de novo coronary lesions or in-stent restenosis will be enrolled.\n\nThe primary objective is to assess target lesion failure at 12 months, defined as the composite of target vessel myocardial infarction or ischemia-driven target lesion revascularization. Secondary objectives include angiographic procedural success, major adverse cardiovascular events, bleeding outcomes, and longer-term clinical results up to 36 months, as well as outcomes across predefined anatomical and clinical subgroups.\n\nThe study seeks to answer whether treatment with the crystalline sirolimus-coated balloon provides a safe and effective revascularization strategy in a real-world population with diverse clinical presentations and lesion characteristics.",[25,26,27,28,29,30],"Coronary Arterial Disease (CAD)","NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI)","Stable Angina, Unstable Angina, NSTEMI","Drug Coated Balloon","ST-Elevation Myocardial Infarction","Silent Ischemia",[32,33,34,35,36],"coronary arterial disease","drug coated ballloon","TLR","TVR","MACE","RECRUITING","2026-03-02",{"date":40,"type":41},"2026-03-03","ACTUAL",{"date":43,"type":41},"2026-01-05",{"date":45,"type":21},"2030-07-06",{"name":47,"class":48},"Fundación Interhospitalaria para la Investigación Cardiovascular FIC","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100566603","leaders-free-iv-rct-biofreedom-ultra-vs-biofreedom-in-hbr-patients-100566603","NCT06657326","LEADERS FREE IV (RCT): BioFreedom™ Ultra vs BioFreedom™ in HBR Patients","Evaluation of the Efficacy (QCA) and Safety of the BioFreedom™ Ultra Drug Coated Stent in Patients With High Bleeding Risk and Coronary Artery Disease Undergoing Percutaneous Coronary Intervention","Inclusion Criteria:\n\n1. Patients at high bleeding risk (HBR) with an indication for PCI who can tolerate at least one month of DAPT. This includes patients with stable angina, silent ischemia, acute coronary syndromes (ACS) (STEMI and NSTEMI), de novo lesions in native arteries with diameter stenosis \\>70% by visual estimation and evidence of ischemia in the territory of the target vessel(s).\n2. Patients meet ARC-HBR definition i.e at least 1 major or 2 minor criteria.\n\nExclusion Criteria:\n\n1. Pregnant and breastfeeding women\n2. Age \\\u003C18 years old\n3. Patients lacking capacity (i.e. patients suffering from dementia and others) to provide informed consent\n4. Patients expected not to comply with 1 month DAPT\n5. Active bleeding at the time of inclusion\n6. Procedure requires the use of non-study stents, or alternative therapeutic options not followed by stent implantation (angioplasty only, atherectomy only)\n7. Number of target lesions \\>2\n8. Patient requires a stent of diameter \\\u003C2.25mm\n9. Patient requires a stent of diameter \\>4.0mm\n10. Isolated ostial lesions within 3 mm of the origin of LAD or LCx (left main lesions involving the ostia of the LAD and\u002For LCx are eligible)\n11. Patient has known left ventricular ejection fraction (LVEF) \\\u003C30% (LVEF may be obtained at the time of the index procedure if the value is unknown and the investigator believes it is necessary)\n12. Patient with chronic total occlusion(s) as target lesion(s)\n13. Severe calcification that might prevent sufficient expansion of the DES, unless pre-treated with a plaque modification device such as cutting balloon, scoring balloon or intravascular lithotripsy.\n\n    Note: Use of rotational or orbital atherectomy is also permitted.\n14. Cardiogenic shock\n15. Compliance with long-term single anti-platelet therapy unlikely\n16. Known hypersensitivity or contraindication to aspirin, clopidogrel (or to any other P2Y12 inhibitor if applicable), cobalt chromium, stainless steel, zinc, Biolimus A9™ or a sensitivity to contrast media, which cannot be adequately pre-medicated\n17. Any PCI during the previous 12 months\n18. Participation in another clinical study (12 months after index procedure)\n19. Patients with a life expectancy of \\\u003C12 months",{"count":58,"type":21},444,"INTERVENTIONAL",[61],"NA","This study aims to demonstrate that the BioFreedom™ Ultra Drug Coated Stent (DCS) is non-inferior to the BioFreedom™ DCS, with respect to in-stent late lumen loss, and that it has safety characteristics similar to the BioFreedom™ DCS.",[64,65,66,30,67],"Coronary Artery Disease","Chronic Stable Angina","Unstable Angina","Acute Coronary Syndrome","2025-06-03",{"date":70,"type":41},"2025-06-05",{"date":72,"type":41},"2024-12-18",{"date":74,"type":21},"2030-12",{"name":76,"class":77},"Biosensors Europe SA","INDUSTRY",6]