[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"coronary-computed-tomographic-angiography\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:coronary-computed-tomographic-angiography":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":5},"100653317","investigation-to-assess-the-effects-of-drug-coated-balloons-for-treatment-of-plaques-erosions-causing-acute-coronary-syndromes-100653317",false,"NCT07783880","Investigation to Assess the Effects of Drug-COATED Balloons for Treatment of Plaques Erosions Causing Acute Coronary Syndromes","Drug-COATED Balloons for Treatment of Plaques Erosions Causing Acute Coronary Syndromes","DCB-PE","Inclusion Criteria:\n\n1. Patients aged ≥18 years presenting with MI where the culprit de-novo (stent restenosis\u002Fthrombosis excluded) lesion has a Thrombolysis in Myocardial Infarction (TIMI) flow of ≥ I with signs of thrombus on angiographic (or CCTA followed by conventional coronary angiography) evaluation located in a native coronary artery (a by-pass graft vessel excluded) addressable by PCI;\n2. OCT criteria (all 4 should be present):\n\n   1. Presence of thrombus\n   2. Absence of an overt ruptured plaque flap\n   3. Area of stenosis of ≥ 50%\n   4. Presence of atherosclerotic, predominantly lipidic or fibrotic plaque underneath (absence of major calcifications or calcified noduli)\n\nExclusion Criteria:\n\n1. Culprit lesion located or extending in the Left Main coronary artery;\n2. Presence of large coronary aneurysms;\n3. Large thrombus burden (extending for more than \\> 15 mm);\n4. Patients with severe tortuous lesions (OCT judged not possible);\n5. Spontaneous coronary dissection is suspected;\n6. Renal insufficiency (Glomerular Filtration Rate (GFR) \\\u003C 29 ml\u002Fmin\u002F1.73m2; Kidney Disease Outcomes Quality Initiative (KDOQI) stage 4 and 5);\n7. Life expectancy less than 2 years;\n8. Pregnant or lactating women;\n9. Patients currently participating in another trial;\n10. Patients that are unable or unwilling to provide consent;\n\n    OCT exclusion criteria:\n11. Overt plaque rupture;\n12. Thrombosed protruding calcified noduli;\n13. Predominantly calcific lesions with calcium arc \\> 180° in the target segment;\n14. Presence of calcium plaque of \\> 0.4 mm thick;","ALL","18 Years",{"count":20,"type":21},62,"ESTIMATED","INTERVENTIONAL",[24],"NA","Drug eluting balloon angioplasty might be a better alternative than medical treatment or stenting in subjects with plaque erosion, which is the second most common cause of myocardial infarction.\n\nThe main objective of this pilot study is to gain clear insights on the effect of percutaneous coronary intervention (PCI) with size matched DCB (SeQuent) as compared to treatment with GP IIbIIIa inhibitor or heparin \\& dual antiplatelet therapy in a predominantly Caucasian population at 2 days and at 1 year after the procedure.",[27,28,29,30,31,32],"Myocardial Infarction","Percutaneous Coronary Intervention (PCI)","Medical Treatment","Coronary Computed Tomographic Angiography","Computed Tomography","Optical Coherence Tomography (OCT)",[34,35,36,37],"Plaque erosion","drug-coated balloon","CT-FFR","Minimum Lumen Area","NOT_YET_RECRUITING","2026-08-21",{"date":41,"type":42},"2026-08-25","ACTUAL",{"date":44,"type":21},"2026-10-01",{"date":46,"type":21},"2030-01-01",{"name":48,"class":49},"3W-Research Collaboration Group","OTHER"]