"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

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

Treatments tested in this trial

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

Treatment groups

50 Participants
are divided into 2 treatment groups