NCT07711106Recruiting
"Expert IVUS-Eye" vs. IVUS-guided Left Main Bifurcation PCI
"IVUS-Trained Eye" vs. Intravascular Ultrasound in Left Main Bifurcation Stenting: A Prospective Randomized Trial
Source: ClinicalTrials.gov · Last updated 17 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 7 Jul 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
- Diseases
- Coronary artery disease
- NCT number
- NCT07711106
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 1 Jul 2026 to the primary completion date, 1 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior PCI in the target segment
- 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;
Other illness
- ST-elevation myocardial infarction (STEMI) within the preceding 72 hours
- History of coronary artery bypass grafting (CABG)
- Known contraindication or hypersensitivity to everolimus, platinum-chromium, or to anticoagulants.
Other
- Cardiogenic shock
- Isolated (non-bifurcation) left main lesion
- 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
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.