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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.
Stenting of the left main coronary artery in bifurcation lesions remains one of the most technically demanding tasks in interventional cardiology. Stent implantation quality is directly linked to the risk of adverse outcomes. Minimal stent area (MSA), as measured by IVUS, is a key predictor of adverse clinical outcomes. In practice, however, many centers continue to rely on angiographic assessment alone when performing various left main bifurcation stenting techniques. Proponents of this approach cite extensive clinical experience, anatomical familiarity, and IVUS-informed intuition developed over time (a "trained eye"). To date, no randomized data exist comparing outcomes of left main stenting between an IVUS-guided approach and a visually/experience-guided approach. Investigators hypothesize that, when combined with mandatory bifurcation optimization steps (e.g., proximal optimization technique [POT], kissing balloon inflation [KBI]), an angiography-only approach performed by an IVUS-experienced physician is non-inferior to a standard IVUS-guided approach, as assessed by post-PCI IVUS stent planimetric characteristics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVUS-Guided Approach | Active Comparator | Pre-procedural IVUS will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent. |
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| "Trained Eye" (Angiography-Guided) Approach | Experimental | Stent sizing and procedural optimization guided by angiographic visual assessment and operator experience, with only IVUS assessment after intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVUS-Guided LM PCI | Procedure | 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:
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Immediately post-procedure |
| 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 | Immediately post-procedure |
| 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 | 1 year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| All individual components of DoCE at all time points. | Proportion of patients (%) achieving individual components of DoCE. | 1 year follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aleksei A. Prokhorikhin, PhD | Contact | +79137178040 | aa.prohorihin@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health | Recruiting | Saint Petersburg | Russia |
Demographic, clinical, procedural and follow-up data. No personal data will be shared
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Web-based randomization platform (Sealed Envelope), performed after eligibility confirmation and informed consent
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|
| "Trained Eye" (Angiography-Guided) LM PCI | Procedure | 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:
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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