[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587476":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":33,"locations":42,"responsibleParty":62,"collaborators":32,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":32,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":32,"enrollmentInfo":74,"targetDuration":32,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":87,"overallStatus":98,"whyStopped":32,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Cardiocentro Ticino","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sirolimus-eluting DEB (Selution SLR) therapy + Guidelines-directed medical therapy","EXPERIMENTAL","Selution SLR sirolimus-eluting balloon additional to guidelines-directed medical therapy for the preventive treatment of non-flow limiting vulnerable coronary lesions",[13],"Device: Sirolimus drug eluting ballooon therapy",{"label":15,"type":16,"description":15,"interventionNames":17},"Guidelines-directed medical therapy","ACTIVE_COMPARATOR",[18],"Drug: Optimal guidelines-directed medical therapies (GDMT)",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Sirolimus drug eluting ballooon therapy","Non-flow limiting vulnerable coronary plaques are treated using sirolimus drug eluting balloon therapy additional to guidelines directed medical therapy.",[9],[26],"DEB-GDMT",{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Optimal guidelines-directed medical therapies (GDMT)","Optimal guidelines-directed medical therapies (GDMT) to reduce plaque burden and vulnerability for non-flow limiting vulnerable plaques",[15],null,[34,39],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Marco Valgimigli Marco Valgimigli, MD, PhD","CONTACT","+41 (0) 91 811 51 11","marco.valgimigli@eoc.ch",{"name":40,"role":36,"phone":37,"phoneExt":32,"email":41},"Enrico Frigoli Frigoli, MD, MHS","enricofrigoli@eoc.ch",[43],{"facility":44,"status":32,"city":45,"state":32,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Istituto Cardiocentro Ticino - EOC","Lugano","6900","Switzerland","CH",{"type":50,"coordinates":51},"Point",[52,53],8.96004,46.01008,{"lat":53,"lon":52},[56,59],{"name":57,"role":36,"phone":37,"phoneExt":32,"email":58},"Enrico Frigoli, MD, MHS","enrico.frigoli@eoc.ch",{"name":60,"role":61,"phone":32,"phoneExt":32,"email":32},"Marco Valgimigli, Md, PhD","PRINCIPAL_INVESTIGATOR",{"type":61,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Marco Valgimigli","Prof. Dr. Med. Marco Valgimigli, Deputy Chief","100587476","ticin-pilot-study-sirolimus-eluting-balloon-for-stabilization-and-regression-of-non-obstructive-coronary-plaques-100587476",false,"NCT06928883","Ticin Pilot Study: Sirolimus-Eluting Balloon for Stabilization and Regression of Non-Obstructive Coronary Plaques.","TITAN-PARADISE Pilot: TicIn for the Treatment of Coronary Lesions - Plaque Regression and Stabilization With Sirolimus Elution (Pilot Study)","Inclusion Criteria:\n\nPotential subjects must fulfill all following inclusion criteria:\n\n1. Multivessel coronary artery disease with ACS within 90 days prior to inclusion and successful interventional treatment of the culprit lesion\n2. Presence of ≥ 2 de novo non-culprit lesion without hemodynamic relevance in two different coronary vessels (demonstrated either by wire-based or angiography-based coronary physiology) and with MaxLCBI4mm ≥ 325 at baseline IVUS-NIRS\n3. Age ≥ 18 years\n4. Written informed consent\n\nExclusion Criteria:\n\nPatients are not eligible if any of the following applies:\n\n1. Non culprit lesion involving the left main and\u002For ostial left coronary artery, ostial left circumflex artery or ostial right coronary artery;\n2. Non-culprit lesion in a previously stented segment (i.e. within 15 mm from the previously implanted stent);\n3. Non-culprit lesion involving small vessel (\\\u003C3.0 mm) deemed not suitable to PCI,\n4. Non-culprit lesion located in a bypass graft or in a grafted vessel;\n5. Severe renal impairment (eGFR\\\u003C15ml\u002Fmin\u002F1.73m2) or patient on dialysis treatment;\n6. Known pregnancy r breast-feeding patients;\n7. Life expectancy \\\u003C2 year due to other severe non-cardiac disease;\n8. Legally incompetent to provide informed consent;\n9. Partecipation in another clinical study with an investigational product","ALL","18 Years",{"count":75,"type":76},24,"ESTIMATED","INTERVENTIONAL",[79],"NA","The goal of this pilot clinical trial is to evaluate the use of the Selution SLR sirolimus-eluting balloon, in addition to guideline-directed medical therapy (GDMT), for the preventive treatment of non-flow-limiting vulnerable coronary lesions, compared to GDMT alone, in adult patients with multivessel coronary artery disease and a recent acute coronary syndrome (within 90 days).\n\nThe main research question is:\n\nDoes the use of the Selution SLR sirolimus-eluting balloon in combination with GDMT reduce the progression and vulnerability of non-flow-limiting vulnerable coronary plaques?\n\nParticipants will undergo\n\n* PCI procedure with baseline IVUS-NIRS assessment\n* Follow-up coronary angiography at 6 months with IVUS-NIRS assessment\n* Clinical follow-up at 3, 6, and 24 months after study enrollment",[82,83,84,85,86],"Coronary Arterial Disease (CAD)","Vulnerable Coronary Plaques","Multivessel Coronary Artery Disease","Coronary Vessel","Acute Coronary Syndromes (ACS)",[82,83,88,89,86,90,91,92,93,94,95,96,97],"Multivessel coronary artery disease","Coronary vessel","Non-flow limiting vulnerable coronary plaques","Sirolimus-eluting DEB","DEB Selution SLR","Guidelines-directed medical therapies (GDMT)","IVUS-NIRS","MaxLCBI4mm","MaxLCBI4mm≥325","Lipid Core Burden Index (LCBI)","NOT_YET_RECRUITING","2025-04-08",{"date":101,"type":102},"2025-04-15","ACTUAL",{"date":104,"type":76},"2025-04",{"date":106,"type":76},"2028-12-31",{"name":5,"class":6},1]