[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100491092":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":44,"responsibleParty":61,"collaborators":63,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":26,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Cardiocentro Ticino","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Magic Touch drug eluting balloon based strategy - 6\u002F12 months invasive follow up","EXPERIMENTAL","Patients randomized to DEB-based strategy will receive treatment with DEB (Magic Touch, Concept Medical®) throughout the entire lesion length, followed by final assessment with FFR and IVUS at 6 or 12 months in a randomized fashion.",[13],"Device: Magic Touch drug eluting balloon based strategy",{"label":15,"type":16,"description":17,"interventionNames":18},"Drug eluting stent based strategy - 6\u002F12 months invasive follow up","ACTIVE_COMPARATOR","Percutaneous transluminal coronary angioplasty and drug eluting stent implantation according to local standard of care, including optimization techniques (e.g. post-dilatation) which are left at operators' discretion, followed by final assessment with FFR and IVUS at 6 or 12 months in a randomized fashion.",[19],"Device: Drug-eluting stent-based strategy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Magic Touch drug eluting balloon based strategy","Adult patients with chronic coronary syndrome deemed suitable for percutaneous intervention and significant long de-novo coronary lesion randomized in the experimental arm will receive treatment with drug eluting balloon (Magic Touch®) followed by invasive follow up (FFR and IVUS) at 6 ot 12 months in a randomized fashion.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Drug-eluting stent-based strategy","Adult patients with chronic coronary syndrome deemed suitable for percutaneous intervention and significant long de-novo coronary lesion randomized in the control arm will receive treatment with drug-eluting stent followed by invasive follow up (FFR and IVUS) at 6 ot 12 months in a randomized fashion.",[15],[32],{"name":33,"affiliation":34,"role":35},"Marco Valgimigli, M.D., Ph.D","Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano,","PRINCIPAL_INVESTIGATOR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+410918115111","marco.valgimigli@eoc.ch",{"name":42,"role":38,"phone":26,"phoneExt":26,"email":43},"Enrico Frigoli, M.D.","enrico.frigoli@eoc.ch",[45],{"facility":46,"status":47,"city":48,"state":26,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Marco Valgimigli","RECRUITING","Lugano","6900","Switzerland","CH",{"type":53,"coordinates":54},"Point",[55,56],8.96004,46.01008,{"lat":56,"lon":55},[59],{"name":60,"role":38,"phone":39,"phoneExt":26,"email":26},"Enrico Frigoli, MD",{"type":35,"investigatorFullName":46,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Coordinating Principal Investigator",[64],{"name":65,"class":6},"University of Bern","100491092","phase-4-ticin-for-the-treatment-of-coronary-lesions-with-drug-eluting-ballons-100491092",false,"NCT05674630","Ticin for the Treatment of Coronary Lesions With Drug Eluting Ballons","TicIn for the Treatment of coronAry lesioNs With Drug Eluting Balloons","TITAN-DEB","Inclusion Criteria:\n\n1. Adult patients (≥18 years old) with chronic coronary syndrome deemed suitable for PCI\n2. At least one significant de-novo coronary lesion (defined as diameter stenosis \\> 50% on angiography, with flow limiting features, confirmed with FFR ≤0.80 or iFR ≤0.89 and intended implantation of a long (≥30 mm) DES based on IVUS findings\n3. Written informed consent\n\nExclusion Criteria:\n\n1. Patients referred to the index procedure for an acute coronary syndrome\n2. Target lesion involving the left main and\u002For ostial left coronary artery, ostial left circumflex artery or ostial right coronary artery\n3. Severe renal impairment (eGFR\\\u003C15ml\u002Fmin\u002F1.73m2) or patient on dialysis treatment\n4. Spontaneous coronary artery dissection (SCAD)\n5. Contraindications to adenosine administration (e.g. moderate to severe asthma or chronic obstructive pulmonary disease, heart rate \\\u003C50 beats\u002Fmin and systolic blood pressure \\\u003C90 mmHg)\n6. Known pregnancy or breast-feeding patients\n7. Life expectancy \\\u003C1 year due to other severe non-cardiac disease\n8. Legally incompetent to provide informed consent\n9. Participation in another clinical study with an investigational product","ALL","18 Years",{"count":77,"type":78},130,"ESTIMATED","INTERVENTIONAL",[81],"PHASE4","The goal of this clinical trial is to compare the use of a specific drug eluting balloon (Magic Touch, Concept Medical®) versus standard drug eluting stent based strategies in patients with long coronary lesions.\n\nParticipants with chronic coronary disease and long coronary stenosis will be randomly assign to be treated either with Magic Touch balloon or drug eluting stent.",[84],"Chronic Coronary Syndrome",[86,87,88,89,90,91,92,93,94,95,96],"adult","chronic coronary syndrome","percutaneous intervention","significant de novo coronary lesion","FFR≤0.80","iFR≤0.89","long DES (≥30 mm)","coronary lesion","drug eluting balloon","drug eluting stent","Magic Touch drug eluting balloon","2023-09-06",{"date":99,"type":100},"2023-09-08","ACTUAL",{"date":102,"type":100},"2023-02-21",{"date":104,"type":78},"2030-12-01",{"name":5,"class":6},1]