[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vulnerable-coronary-plaques\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vulnerable-coronary-plaques":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,57,89],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100601244","drug-eluting-balloon-treatment-vs-guideline-directed-medical-therapy-for-the-treatment-of-lipid-rich-plaques-100601244",false,"NCT07107971","Drug-Eluting Balloon Treatment vs. Guideline-Directed Medical Therapy for the Treatment of Lipid-Rich Plaques","Drug-Eluting Balloon Treatment Versus Guideline-Directed Medical Therapy for the Treatment of Lipid-Rich Plaques: A Randomized Controlled Trial","DELETE-LRP","Inclusion Criteria:\n\n* Presenting with acute coronary syndrome (ACS);\n* Successful PCI of a native coronary artery or major side branch;\n* At least 2 native coronary arteries are accessible for invasive coronary imaging; i.e. not totally occluded and \\>2 mm and \\\u003C6 mm reference vessel diameter.\n\nExclusion Criteria:\n\n* Hemodynamically unstable (presence of cardiogenic shock, need for intubation, need for inotropes);\n* Known hypersensitivity to paclitaxel;\n* Procedural complications of the index PCI;\n* Known renal insufficiency, i.e. eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2;\n* Hypersensitivity or allergy to contrast with inability to administer steroid and antihistamine premedication;\n* Presence of a comorbid condition with a life expectancy of less than one year;\n* Body weight \\>250 kg;\n* Subject belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff) or is unable to read or write.","ALL","18 Years",{"count":20,"type":21},400,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to find out whether treating vulnerable plaques in the coronary arteries with a drug-coated balloon can make them less dangerous than using standard medication alone. The study includes adults with acute coronary syndrome (a type of heart problem caused by reduced blood flow in the coronary arteries).\n\nThe main questions the study aims to answer are:\n\n* Does the drug-coated balloon reduce the amount of fat inside the plaque more than medication alone?\n* Is this treatment safe for patients?\n\nParticipants will:\n\n* Undergo imaging of their coronary arteries during their planned heart procedure (PCI)\n* Be randomly assigned to receive either a drug-coated balloon treatment or no extra treatment\n* Undergo a heart scan (CT scan of the coronary arteries) within 2 weeks and again around 9 months after the procedure.\n* Undergo a second heart catherization 9 months later to examine changes in the plaque.",[27,28,29,30,31,32,33],"Coronary Artery Disease","Atheroscleroses","Cardiovascular Disease","Vulnerable Coronary Plaques","Vulnerable Plaque","Lipid-Rich Atherosclerosis of Coronary Artery","Acute Coronary Syndromes (ACS)",[35,36,37,38,39,40,41,42,43],"Lipid-rich plaque","Vulnerable plaque","Near-infrared spectroscopy","Drug-coated balloon","Drug-eluting balloon","Paclitaxel-eluting balloon","Intravascular Ultrasound","Coronary computed tomography angiography","AI-QCT","RECRUITING","2026-01-14",{"date":47,"type":48},"2026-01-15","ACTUAL",{"date":50,"type":48},"2025-11-04",{"date":52,"type":21},"2033-01",{"name":54,"class":55},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",1,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":22,"phases":67,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":56},"100581840","phase-4-effectiveness-of-interventional-therapy-for-non-flow-limiting-vulnerable-plaques-100581840","NCT06855537","Effectiveness of Interventional Therapy for Non-Flow-Limiting Vulnerable Plaques","Randomized Controlled Study on the Effectiveness of Interventional Therapy for Non-Flow-Limiting Vulnerable Plaques","Inclusion Criteria Clinical Inclusion Criteria 1. Males or non-pregnant females aged 18-80 years 2. Clinically diagnosed with acute coronary syndrome (including unstable angina, ST-segment elevation myocardial infarction, and non-ST-segment elevation myocardial infarction) 3. Patients willing and able to sign a written informed consent form Angiography, QFR, and OCT Inclusion Criteria\n\n1. Successful completion of angiography, QFR, and OCT examinations\n2. Successful treatment of all culprit lesions and flow-limited lesions (QFR ≤ 0.8)\n3. Reference vessel diameter between 2.5-4.0 mm on imaging assessment\n4. Lesion length ≤40 mm\n5. At least one significant stenosis (diameter reduction \\>50%) demonstrated by angiography, with QFR \\>0.80 and OCT-defined TCFA (fibrous cap thickness \\\u003C65μm, lipid arc \\>90°)\n\nExclusion Criteria Clinical Exclusion Criteria\n\n1. Patients with contraindications to dual antiplatelet therapy (DAPT) or planning to discontinue DAPT within one year\n2. Patients with other major illnesses and a life expectancy \\\u003C2 years\n3. Patients scheduled for cardiac surgery or major non-cardiac surgery\n4. Women who are breastfeeding, pregnant, or planning pregnancy during the study\n5. Patients with severe heart failure (NYHA class III-IV or Killip class III-IV or left ventricular ejection fraction \\\u003C35%)\n6. Patients with estimated glomerular filtration rate \\\u003C30 mL\u002F(min·1.73 m²)\n7. Patients with allergy to contrast agents or DES drugs\n8. Patients currently enrolled in other clinical studies Angiographic Exclusion Criteria\n\n1\\. Patients for whom CABG is the preferred treatment 2. Target lesion is a previously stented lesion 3. Target lesion is a post-bypass lesion 4. Target lesion is a heavily calcified or angulated lesion 5. Target lesion requires dual-stent technique 6. Target lesion is a left main coronary artery lesion.","80 Years",{"count":66,"type":21},2190,[68],"PHASE4","The aim of this clinical trial is to explore the optimal preventative treatment strategy for non-flow-limiting vulnerable plaques. The main question it aims to answer is:\n\nCan interventional therapy further improve the outcome of non-flow-limiting vulnerable plaques on top of optimal pharmacologic therapy?\n\nResearchers will randomly assign patients who meet the inclusion criteria to preventative intervention plus optimal drug therapy (experimental group) or optimal drug therapy alone (control group).\n\nParticipants will:\n\nAssigned to the control group: optimized drug therapy consisting of lifestyle improvement and intensive drug therapy including high-dose statin or other therapy to achieve target levels (low-density lipoprotein cholesterol \\\u003C1.4 mmol\u002FL and decreased by 50% compared to the baseline). Lifestyle improvement and risk factor management included smoking cessation, nutritional optimization, physical activity, compliance with prescribed medications, and control of diabetes and hypertension.\n\nAssigned to the experimental group: all non-flow-limiting vulnerable plaques were treated with conventional second-generation drug-eluting stents. After the procedure, participants received dual antiplatelet therapy for about 12 months as well as other medications in the control group.",[71,30,72,33],"Coronary Arterial Disease (CAD)","Thin-cap fIbroatheroma",[74,75,76,77,78,79,33,30],"Optical Coherence Tomography (OCT)","Percutaneous Coronary Intervention (PCI)","Randomized Controlled Trial (RCT)","Optimal Medical Therapy","Drug Eluting Stent (DES)","Quantitative Flow Ratio (QFR)","2025-11-25",{"date":82,"type":48},"2025-12-02",{"date":84,"type":48},"2025-11-03",{"date":86,"type":21},"2027-09-01",{"name":88,"class":55},"Beijing Anzhen Hospital",{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":99,"conditions":100,"keywords":103,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":56},"100587476","ticin-pilot-study-sirolimus-eluting-balloon-for-stabilization-and-regression-of-non-obstructive-coronary-plaques-100587476","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",{"count":97,"type":21},24,[24],"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",[71,30,101,102,33],"Multivessel Coronary Artery Disease","Coronary Vessel",[71,30,104,105,33,106,107,108,109,110,111,112,113],"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":117,"type":48},"2025-04-15",{"date":119,"type":21},"2025-04",{"date":121,"type":21},"2028-12-31",{"name":123,"class":55},"Cardiocentro Ticino"]