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"Expert IVUS-Eye" vs. IVUS-guided Left Main Bifurcation PCI

RecruitingNAAges 18 Years - anyAllFederal State Budgetary Institution, V. A. Almazo…
NCT07711106 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a prospective, randomized, controlled trial comparing two strategies for optimizing stent implantation during bifurcation stenting of the left main coronary artery (LM): an intravascular ultrasound (IVUS)-guided approach versus a "IVUS-trained eye" approach based on angiographic assessment and operator experience. All patients receive the same stent brand and procedure steps to minimize variability. The primary objective is to compare the planimetric stent appearance between two strategies.

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📋 Eligibility rules (as published)
Inclusion Criteria: * De novo lesion in an unprotected left main coronary artery, indicated for bifurcational stenting (provisional or 2-stent) * Patient referred for elective or delayed (non-emergency) stenting * Technical feasibility of performing IVUS * Signed informed consent Exclusion Criteria: * ST-elevation myocardial infarction (STEMI) within the preceding 72 hours * Cardiogenic shock * Isolated (non-bifurcation) left main lesion * Prior PCI in the target segment * Diameter of one of the left main main branches \< 2 mm * Occlusion in the proximal segment of one of the main left main branches without the possibility of simultaneous recanalization * History of coronary artery bypass grafting (CABG) * Severe comorbidity with expected life expectancy \< 1 year * Participation in another interventional study * Patient is a woman who is pregnant or nursing; * Female patient of childbearing potential, i.e. who are not surgically sterile or post-menopausal (defined as no menses for 2 years without an alternative cause); * IVUS is strictly required for pre-PCI lesion severity assessment * Patients unable to tolerate, obtain or comply with dual antiplatelet therapy for at least 6 months in stable patients and 1 year in ACS patients; * Known contraindication or hypersensitivity to everolimus, platinum-chromium, or to anticoagulants.
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What it tests

  • IVUS-Guided LM PCI
  • "Trained Eye" (Angiography-Guided) LM PCI
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Where

1 site
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Saint Petersburg, Russia
🤝 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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