[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537250":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":31,"responsibleParty":49,"collaborators":20,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":20,"enrollmentInfo":61,"targetDuration":20,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"National Institute of Cardiology, Warsaw, Poland","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Drug-coated balloon","EXPERIMENTAL","Patients will undergo PCI of the native coronary CTO with a DCB.",[13],"Device: Paclitaxel Drug-coated balloon",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Paclitaxel Drug-coated balloon","Percutaneous coronary intervention of the actual CTO body with a paclitaxel drug-coated balloon.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Maksymilian Opolski","National Institute of Cardiology","PRINCIPAL_INVESTIGATOR",[27],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","0048(22)3434127","mopolski@ikard.pl",[32],{"facility":24,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Warsaw","Masovian Voivodeship","04-628","Poland","PL",{"type":40,"coordinates":41},"Point",[42,43],21.01178,52.22977,{"lat":43,"lon":42},[46],{"name":47,"role":28,"phone":20,"phoneExt":20,"email":48},"Agnieszka Zdziennicka","azdziennicka@ikard.pl",{"type":50,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100537250","drug-coated-balloon-in-native-chronic-total-occlusion-percutaneous-coronary-intervention-100537250",false,"NCT06275386","Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention","Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention (IMAGINATION)","IMAGINATION","Inclusion Criteria:\n\n* clinical indication for CTO PCI as determined by the local heart team (presence of angina or equivalent symptoms and\u002For documented ischemia or viability)\n* native CTO lesion as defined by invasive coronary angiography\n* informed consent for participation in the study\n\nExclusion Criteria:\n\n* \\\u003C18 years of age\n* myocardial infarction\n* cardiogenic shock\n* severe valvular disease\n* estimated life expectancy \\\u003C1 year\n* contraindication to PCI\n* positive pregnancy test or breast-feeding\n* in-stent CTO\n* CTO recanalization using antegrade or retrograde dissection and re-entry techniques","ALL","18 Years",{"count":62,"type":63},30,"ESTIMATED","INTERVENTIONAL",[66],"NA","The IMAGINATION trial is an investigator-initiated, prospective, single-center study of symptomatic patients with a native chronic total occlusion (CTO) undergoing intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) with a drug-coated balloon (DCB). Post-PCI IVUS and fractional flow reserve (FFR) at baseline and at 6-months follow-up will be performed. In addition, patients included in the coronary computed tomography angiography (CCTA) substudy will undergo CCTA at 12-months follow-up. The aim of this study is to evaluate the efficacy and safety of DCB-only approach in native coronary CTO.",[69,70],"Coronary Artery Disease","Total Occlusion of Coronary Artery",[72,73,74],"chronic total occlusion","percutaneous coronary intervention","drug-coated balloon","2025-12-29",{"date":77,"type":78},"2026-01-02","ACTUAL",{"date":80,"type":78},"2024-03-24",{"date":82,"type":63},"2026-05",{"name":5,"class":6},1]