[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"left-main-coronary-artery-stenosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:left-main-coronary-artery-stenosis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"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":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100489230","ultrathin-strut-biodegradable-polymer-sirolimus-eluting-stents-with-p2y12-inhibitor-based-single-antiplatelet-therapy-vs-conventional-dapt-for-unprotected-left-main-coronary-artery-disease-ultimate-lm-100489230",false,"NCT05650411","Ultrathin-strut Biodegradable Polymer Sirolimus-eluting Stents With P2Y12 Inhibitor-based Single Antiplatelet Therapy vs. Conventional DAPT for Unprotected Left Main Coronary Artery Disease (ULTIMATE-LM)","ULTRATHIN-STRUT BIODEGRADABLE POLYMER SIROLIMUS-ELUTING STENTS COMBINED WITH P2Y12 INHIBITOR-BASED SINGLE ANTIPLATELET THERAPY AFTER A SHORT DUAL ANTIPLATELET THERAPY REGIMEN VERSUS CONVENTIONAL DUAL ANTIPLATELET THERAPY FOR UNPROTECTED LEFT MAIN CORONARY ARTERY DISEASE","ULTIMATE-LM","Inclusion Criteria:\n\n* Age ≥18 years.\n* Patient with chronic or acute coronary syndrome (unstable angina, or non-ST-elevation acute coronary syndrome).\n* Subject with significant unprotected (ostial, mid-shaft, or distal) LMCA stenosis who underwent successful LMCA PCI with ≥1 Supraflex Cruz ultrathin-strut biodegradable polymer sirolimus-eluting stent (Sahajanand Medical Technologies Ltd., Surat, India) according to current ESC guidelines on myocardial revascularization and\u002For local Heart Team decision.\n* Subject willing to participate and able to understand, read and sign the informed consent document before the planned procedure.\n\nExclusion Criteria:\n\n* Contraindications to PCI and\u002For DES implantation.\n* Inability to adhere to DAPT for at least 6 months.\n* Patient already on DAPT.\n* Patients on oral anticoagulation.\n* Previous coronary artery bypass surgery.\n* LMCA in-stent restenosis or stent thrombosis.\n* Recent ST-elevation myocardial infarction \\\u003C5 days prior to randomization.\n* Cardiogenic shock\u002Fhemodynamic instability at the time of intervention and\u002For need for mechanical\u002Fpharmacologic hemodynamic support.\n* Participation or planned participation in another clinical trial, except for observational registries.\n* Life expectancy \\\u003C1 year.\n* Pregnancy.","ALL","18 Years",{"count":20,"type":21},828,"ESTIMATED","INTERVENTIONAL",[24],"NA","The management of patients with unprotected left main coronary artery (LMCA) disease undergoing percutaneous coronary intervention (PCI) in contemporary interventional cardiology practice remains matter of intense debate. Particularly, the combination of the optimal drug-eluting stent (DES) selection and antiplatelet regimen for patients who require LMCA PCI remains undetermined.\n\nNewer-generation drug-eluting stents with ultrathin-strut metallic platforms have been shown to reduce the risk of target lesion failure compared with thicker-strut drug-eluting stents among all-comer patients undergoing PCI, a difference mainly driven by a lower risk of ischemia-driven target lesion revascularization. In the TALENT prospective, single-blind, multicenter, randomized controlled trial that included 1'435 all-comer patients undergoing PCI, the Supraflex ultrathin-strut biodegradable polymer sirolimus-eluting stent was found non-inferior to the Xience® thin-strut permanent polymer everolimus-eluting stent (Abbott Vascular, USA) with regards to the device-oriented composite clinical endpoint (DoCE), a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization, at 12 months of follow-up. However, the TALENT trial included only 31 (1.5%) lesions located in the left main coronary artery. In the COMPARE 60\u002F80 HBR investigator-initiated, multicenter, prospective randomized trial which included a total of 732 patients at high-bleeding risk undergoing PCI with the Supraflex Cruz ultrathin-strut biodegradable polymer sirolimus-eluting stent or the Ultimaster Tansei (Terumo Corp., Tokyo, Japan), the rates of the primary endpoint of the net adverse clinical endpoint, defined as a composite of cardiac death, myocardial infarction, target vessel revascularization, stroke, or BARC 3 or 5 major bleeding events at 12 months were similar in the Supraflex Cruz and the Ultimaster Tansei groups, meeting the prespecified criterion for non-inferiority of the Supraflex Cruz DES compared to the Ultimaster Tansei DES. The safety and efficacy of the Supraflex Cruz ultrathin-strut biodegradable polymer sirolimus-eluting stent combined with potent P2Y12 inhibitor aspirin-free SAPT among all-comer patients undergoing PCI for complex coronary lesions, such as patients with LMCA stenosis, have however not been investigated to date.\n\nRecent evidence from a large-scale meta-analysis of several randomized clinical trials including \\>32'000 patients indicated that 1-3 months of DAPT followed by P2Y12 inhibitor single antiplatelet therapy (SAPT) after second-generation DES implantation was associated with lower risk for major bleeding and similar risk for adverse ischemic outcomes compared with conventional DAPT. These findings suggest that P2Y12 inhibitor SAPT following a short DAPT course (1-3 months) may represent a valuable treatment option for patients undergoing PCI with newer-generation DES compared to standard conventional 12 months DAPT, but this strategy has never been investigated in dedicated randomized clinical trials focused on patients at highest-risk for ischaemic events, such as patients undergoing LMCA PCI.\n\nThe ULTIMATE-LM randomized trial aims at filling this current gap of knowledge, which may have large impact on clinical practice and international guidelines. ULTIMATE-LM will be the first randomized clinical trial to investigate the safety and efficacy of a novel ultrathin-strut biodegradable polymer drug-eluting stent (Supraflex Cruz, Sahajanand Medical Technologies Ltd., Surat, India)) combined with P2Y12 inhibitor-based single antiplatelet therapy among patients undergoing PCI for LMCA disease.",[27],"Left Main Coronary Artery Stenosis",[29,30,31,32,33,34],"P2Y12 inhibitor-based single antiplatelet therapy","Dual antiplatelet therapy","Left main coronary artery disease","Percutaneous coronary intervention","Ultrathin-strut","Drug-eluting stent","RECRUITING","2026-04-28",{"date":38,"type":39},"2026-05-04","ACTUAL",{"date":41,"type":39},"2026-04-26",{"date":43,"type":21},"2032-05-01",{"name":45,"class":46},"IGLESIAS Juan Fernando","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":4},"100624364","compete-lm-trial-drug-coated-balloon-enhanced-provisional-stenting-in-complex-left-main-disease-100624364","NCT07408674","COMPETE-LM Trial: Drug-Coated Balloon-Enhanced Provisional Stenting in Complex Left Main Disease.","The COMPETE-LM Trial: A Physician-initiated Randomized Clinical Trial (RCT) Comparing Conventional Provisional Stenting With Drug-coated Balloon-enhanced Provisional Stenting for the Treatment of Complex Left Main (LM) Coronary Artery Disease.","COMPETE-LM","Inclusion Criteria:\n\n1. Distal left main stem bifurcation stenosis type Medina 1,1,1 or 0,1,1 with indication for revascularization.\n2. Left main diameter ≤6.00 mm.\n3. LAD and LCx diameter both \\>2.75 mm, evaluated by visual estimation.\n\nExclusion Criteria:\n\n1. Subjects with ages 18 or below at the time of the procedure.\n2. Female subjects who may be pregnant or breast-feeding at the time of the procedure.\n3. Previous PCI of the left main bifurcation.\n4. Chronic total occlusion of the LAD or LCx.\n5. Trifurcating left main requiring treatment of the 3 branches.\n6. LAD and LCx reference sizes are out of the sizing ranges of the used DES\u002FDCB families.\n7. In-stent restenosis as target lesion.\n8. Previous coronary artery bypass graft (CABG) with any patent graft on the left coronary system.\n9. ACS-STEMI (ST-Segment Elevation Myocardial Infarction) due to LM disease.\n10. Cardiogenic shock.\n11. Left ventricular ejection fraction below 35%.\n12. Decision to use mechanical circulatory support for protected PCI.\n13. Contraindication to a minimum of 3 months double antiplatelet and long-term single antiplatelet therapy (or adapted, in case of indication for anticoagulation).\n14. Associated significant valvular disease.\n15. Renal insufficiency with glomerular filtration rate (GFR) \\\u003C 20.\n16. Life expectancy less than one year.",{"count":57,"type":21},186,[24],"Prospective, physician-initiated, multicenter, randomized, single-blind, controlled trial.\n\nParticipants will be randomized (1:1) to a DCB-enhanced strategy (study group) or a conventional strategy (control group).\n\nThe study aims to compare the clinical outcomes of conventional provisional stenting (Angiolite in the main branch, with optional side branch stenting if compromised) versus DCB enhanced provisional stenting (Angiolite in the main branch plus Essential Pro in the side branch) in patients with complex left main bifurcation stenosis indicated to receive non-urgent percutaneous coronary intervention (PCI).\n\nTarget lesions, both main vessel and side branch, will be treated using iVascular devices, with patients randomized into two arms. In one arm, treatment will be performed exclusively with the Angiolite sirolimus-eluting stent (Angiolite, iVascular) in the main vessel, while in the other arm, the Angiolite will be used in the main vessel and the Essential Pro paclitaxel drug-eluting balloon (Essential Pro, iVascular) in the side branch. Non-target lesions may be treated with any commercially available devices according to their approved indications.",[61,27,62],"Complex Left Main Bifurcation Stenosis","Coronary Bifurcation Stenosis",[64,65,66,27,67,68,69,70,71,72,73,74,75],"Essential Pro Paclitaxel","Angiolite","Left Main Artery","Left Main Coronary Artery","Left Main Bifurcation Stenosis","Coronary Disease","Coronary Artery Disease","Complex Left Main Disease","Drug Eluting Balloon","Drug Coated Balloon","Provisional Stenting","Sirolimus Eluting Stent","NOT_YET_RECRUITING","2026-02-06",{"date":79,"type":39},"2026-02-13",{"date":81,"type":21},"2026-04",{"date":83,"type":21},"2029-05",{"name":85,"class":86},"Rede Optimus Hospitalar SA","NETWORK"]