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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)

RecruitingNAAges 18 Years - anyAllIGLESIAS Juan Fernando
NCT05650411 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. Newer-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 siroli

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥18 years. * Patient with chronic or acute coronary syndrome (unstable angina, or non-ST-elevation acute coronary syndrome). * 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/or local Heart Team decision. * Subject willing to participate and able to understand, read and sign the informed consent document before the planned procedure. Exclusion Criteria: * Contraindications to PCI and/or DES implantation. * Inability to adhere to DAPT for at least 6 months. * Patient already on DAPT. * Patients on oral anticoagulation. * Previous coronary artery bypass surgery. * LMCA in-stent restenosis or stent thrombosis. * Recent ST-elevation myocardial infarction \<5 days prior to randomization. * Cardiogenic shock/hemodynamic instability at the time of intervention and/or need for mechanical/pharmacologic hemodynamic support. * Participation or planned participation in another clinical trial, except for observational registries. * Life expectancy \<1 year. * Pregnancy.
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What it tests

  • LMCA PCI with Supraflex Cruz ultrathin-strut biodegradable polymer sirolimus-eluting stent (Sahajanand Medical Technologies Ltd., Surat, India).
  • P2Y12 inhibitor-based SAPT after short DAPT
  • Conventional DAPT
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Where

1 site
Zurich University Hospital
Zurich, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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