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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFederal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • IVUS-Guided LM PCI

    Procedure/Surgery

    Coronary 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/Surgery

    Coronary 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

50 Participants
are divided into 2 treatment groups
Group A: IVUS-Guided ApproachActive comparator 1 intervention
Group B: "Trained Eye" (Angiography-Guided) ApproachExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Immediately post-procedure
2

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

Time frame
Immediately post-procedure
3

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

Time frame
1 year follow-up

Secondary outcomes

1

All individual components of DoCE at all time points.

Proportion of patients (%) achieving individual components of DoCE.

Time frame
1 year follow-up

Other outcomes