"Expert IVUS-Eye" vs. IVUS-guided Left Main Bifurcation PCI (NCT07711106) | Clinical Trial Compass
RecruitingNot Applicable
"Expert IVUS-Eye" vs. IVUS-guided Left Main Bifurcation PCI
Russia50 participantsStarted 2026-07-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Relative optimal LM stent expansion
Timeframe: Immediately post-procedure
2
Absolute optimal LM stent expansion
Timeframe: Immediately post-procedure
3
Device-oriented Composite Endpoint (DoCE)
Timeframe: 1 year follow-up
Trial details
NCT IDNCT07711106
SponsorFederal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health