About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
ST-elevation myocardial infarction (STEMI) within the preceding 72 hours
Cardiogenic shock
Isolated (non-bifurcation) left main lesion
Prior PCI in the target segment
Trial design
Parallel
Treatments tested in this trial
IVUS-Guided LM PCI
Procedure/SurgeryCoronary stent - single manufacturer and model ("Calypso", R-Vascular, Russia) used in all patients, to minimize variability related to stent design (strut thickness, cell design, expansion limits). Procedure steps: * Baseline IVUS pullback - assessment of proximal and distal reference segments and lesion length * Stent selection based on IVUS data * Stent implantation * Mandatory optimization: kissing balloon dilation; proximal optimization * Final IVUS pullback to confirm result
"Trained Eye" (Angiography-Guided) LM PCI
Procedure/SurgeryCoronary stent - single manufacturer and model ("Calypso", R-Vascular, Russia) used in all patients, to minimize variability related to stent design (strut thickness, cell design, expansion limits). Procedure steps: * Anatomical assessment based on visual angiographic evaluation * Stent and balloon selection at operator discretion * Stent implantation * Mandatory optimization (same steps: kissing balloon dilation, proximal optimization) * Final IVUS pullback performed only afterward, solely to assess planimetric result (not used to guide the procedure itself)
Treatment groups
Trial outcomes
Primary outcomes
Relative optimal LM stent expansion
Proportion of patients (%) achieving MSA ≥ 90% of the distal reference segment area according to IVUS, assessed after completion of all stenting and optimization steps
Absolute optimal LM stent expansion
Proportion of patients (%) achieving MSA ≥ 11.4 mm² in the left main coronary artery according to IVUS, assessed after completion of all stenting and optimization steps
Device-oriented Composite Endpoint (DoCE)
Proportion of patients (%), achieving the device-oriented Composite Endpoint (DoCE) defined as the composite of: Cardiovascular death, target vessel MI, clinically indicated repeat revascularization of the target lesion at longest follow-up
Secondary outcomes
All individual components of DoCE at all time points.
Proportion of patients (%) achieving individual components of DoCE.
Sponsors and contacts
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