[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"coronary-vessel\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:coronary-vessel":29},{"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":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":5},"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":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"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",[26,27,28,29,30],"Coronary Arterial Disease (CAD)","Vulnerable Coronary Plaques","Multivessel Coronary Artery Disease","Coronary Vessel","Acute Coronary Syndromes (ACS)",[26,27,32,33,30,34,35,36,37,38,39,40,41],"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":45,"type":46},"2025-04-15","ACTUAL",{"date":48,"type":20},"2025-04",{"date":50,"type":20},"2028-12-31",{"name":52,"class":53},"Cardiocentro Ticino","OTHER"]