IVUS-Guided Left Main Stenting: IVUS-Guided vs Trained-Eye Approach

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective randomized comparison of two strategies for optimizing left main bifurcation stenting: an IVUS-guided approach versus an angiography-based, IVUS-experienced (trained eye) approach. All participants receive the same stent type and standard steps like POT and KBI to minimize variability. The primary outcome is post-PCI stent appearance measured by planimetry via IVUS, with the hypothesis that the trained-eye method is non-inferior to IVUS guidance. The study addresses a technical question in a population with de novo unprotected left main disease undergoing bifurcation stenting. Eligibility focuses on elective or delayed procedures with feasible IVUS access; several high-risk conditions exclude participation. The investigation aims to clarify whether expert angiographic assessment can achieve comparable stent optimization to IVUS guidance in this high-stakes setting.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Aleksei A. Prokhorikhin, PhD
• Email: aa.prohorihin@gmail.com
• Phone: +79137178040

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.