[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653317":3},{"organization":4,"outcomesModule":7,"designInfo":62,"detailedDescription":11,"studyPopulation":11,"armGroups":68,"interventions":80,"overallOfficials":11,"centralContacts":89,"locations":95,"responsibleParty":112,"collaborators":11,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":116,"sex":122,"minAge":123,"maxAge":11,"enrollmentInfo":124,"targetDuration":11,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":138,"overallStatus":143,"whyStopped":11,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"3W-Research Collaboration Group","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Optical Coherence Tomography (OCT)-assessed Minimum Lumen Area (MLA) during the control procedure",null,"Day 2-3",[14,17,20],{"measure":15,"description":11,"timeFrame":16},"Coronary Computed Tomography Angiography (CCTA) assessed MLA at 1-year","1 Year",{"measure":18,"description":19,"timeFrame":16},"Target Lesion Failure (TLF) at 1-year","TLF is defined as Cardiac death, Target Vessel-MI (TV-MI), and Clinically-Driven Target Lesion Revascularization (CD-TLR)",{"measure":21,"description":22,"timeFrame":23},"TLF at 2-years","TLF is defined as Cardiac death, TV-MI, and CD-TLR","2 Years",[25,28,31,33,35,37,39,41,43,45,47,49,51,54,56,60],{"measure":26,"description":11,"timeFrame":27},"CCTA-assessed plaque burden at baseline","Baseline",{"measure":29,"description":11,"timeFrame":30},"CCTA-assessed plaque burden post PCI","1 Week",{"measure":32,"description":11,"timeFrame":16},"CCTA-assessed plaque burden at 1-year",{"measure":34,"description":11,"timeFrame":27},"CCTA-assessed lipid pool volume at baseline",{"measure":36,"description":11,"timeFrame":30},"CCTA-assessed lipid pool volume post PCI",{"measure":38,"description":11,"timeFrame":16},"CCTA-assessed lipid pool volume at 1-year",{"measure":40,"description":11,"timeFrame":27},"Computed Tomography Fractionated Flow Reserve (CT-FFR) at baseline",{"measure":42,"description":11,"timeFrame":16},"CT-FFR at 1-year",{"measure":44,"description":11,"timeFrame":27},"Shear stress at lesion level at baseline measured by Elucid software",{"measure":46,"description":11,"timeFrame":16},"Shear stress at lesion level at 1-year measured by Elucid software",{"measure":48,"description":11,"timeFrame":27},"OCT-assessed thrombus volume at baseline",{"measure":50,"description":11,"timeFrame":12},"OCT-assessed thrombus volume at control procedure",{"measure":52,"description":11,"timeFrame":53},"OCT-assessed area of stenosis post index procedure","Periprocedural",{"measure":55,"description":11,"timeFrame":12},"OCT-assessed area of stenosis post control procedure",{"measure":57,"description":58,"timeFrame":59},"OCT-assessed lumen gain","Difference between control and index MLA","Periprocedural and Day 2-3",{"measure":61,"description":11,"timeFrame":12},"OCT-assessed lipid arc at control procedure",{"allocation":63,"interventionModel":64,"interventionModelDescription":11,"primaryPurpose":65,"observationalModel":11,"timePerspective":11,"maskingInfo":66},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":67,"maskingDescription":11,"whoMasked":11},"NONE",[69,75],{"label":70,"type":71,"description":72,"interventionNames":73},"PCI with size matched DCB","ACTIVE_COMPARATOR","PCI with size matched drug-coated balloon",[74],"Device: PCI with size matched DCB",{"label":76,"type":77,"description":11,"interventionNames":78},"GP IIbIIIa inhibitor or heparin & dual antiplatelet therapy","PLACEBO_COMPARATOR",[79],"Drug: GP IIbIIIa inhibitor or heparin & dual antiplatelet therapy",[81,85],{"type":82,"name":70,"description":83,"armGroupLabels":84,"otherNames":11},"DEVICE","Subjects will be treated with PCI with size matched DCB (SeQuent)",[70],{"type":86,"name":76,"description":87,"armGroupLabels":88,"otherNames":11},"DRUG","GP IIbIIIa inhibitor or heparin \\& dual antiplatelet therapy",[76],[90],{"name":91,"role":92,"phone":93,"phoneExt":11,"email":94},"Prof. Elvin Kedhi, MD PhD","CONTACT","+1 514-934-1934","ekedhi@me.com",[96],{"facility":97,"status":11,"city":98,"state":11,"zip":11,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":106,"contacts":107},"Miedziowe Centrum Zdrowia SA","Lubin","Poland","PL",{"type":102,"coordinates":103},"Point",[104,105],16.20149,51.40089,{"lat":105,"lon":104},[108],{"name":109,"role":92,"phone":110,"phoneExt":11,"email":111},"Dr. hab. n. med. Adrian Wlodarczak","+48 76 846 03 00","wlodarczakadrian@gmail.com",{"type":113,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":125,"type":126},62,"ESTIMATED","INTERVENTIONAL",[129],"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.",[132,133,134,135,136,137],"Myocardial Infarction","Percutaneous Coronary Intervention (PCI)","Medical Treatment","Coronary Computed Tomographic Angiography","Computed Tomography","Optical Coherence Tomography (OCT)",[139,140,141,142],"Plaque erosion","drug-coated balloon","CT-FFR","Minimum Lumen Area","NOT_YET_RECRUITING","2026-08-21",{"date":146,"type":147},"2026-08-25","ACTUAL",{"date":149,"type":126},"2026-10-01",{"date":151,"type":126},"2030-01-01",{"name":5,"class":6},1]