Coronary Artery Disease (CAD)EYE-IVUS LMNCT07711106
"Expert IVUS-Eye" vs. IVUS-guided Left Main Bifurcation PCI
A study testing IVUS-Guided LM PCI and "Trained Eye" (Angiography-Guided) LM PCI in people with Coronary Artery Disease (CAD) and Chronic Coronary Syndrome, run by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease (CAD), Chronic Coronary Syndrome, Left Main Coronary Artery Disease
- What is being tested?
- IVUS-Guided LM PCI and "Trained Eye" (Angiography-Guided) LM PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jul 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Saint Petersburg
Alexandra O. Conradi, M.D., Ph.D., +79219931159, konradi@almazovcentre.ru
Aleksei A. Prokhorikhin, M.D., Ph.D., +79137178040, aa.prohorihin@gmail.com
About this study
Official title: "IVUS-Trained Eye" vs. Intravascular Ultrasound in Left Main Bifurcation Stenting: A Prospective Randomized 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.
Read the detailed description
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.
- Conditions
- Coronary Artery Disease (CAD), Chronic Coronary Syndrome, Left Main Coronary Artery Disease, Coronary Bifurcation Lesion
- Being tested
- IVUS-Guided LM PCI, "Trained Eye" (Angiography-Guided) LM PCI
- Keywords
- Intravascular ultrasound, Percutaneous coronary intervention, Left main, Bifurcation, IVUS-trained eye, Stent optimization, Minimal stent area
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVUS-Guided LM PCIProcedure or surgery
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:
- Baseline IVUS pullback - assessment of proximal and distal reference segments and lesion length
- Stent selection based on IVUS data
- Stent implantation
- Mandatory optimization: kissing balloon dilation; proximal optimization
- Final IVUS pullback to confirm result
"Trained Eye" (Angiography-Guided) LM PCIProcedure or surgery
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:
- Anatomical assessment based on visual angiographic evaluation
- Stent and balloon selection at operator discretion
- Stent implantation
- Mandatory optimization (same steps: kissing balloon dilation, proximal optimization)
- Final IVUS pullback performed only afterward, solely to assess planimetric result (not used to guide the procedure itself)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: IVUS-Guided LM PCI |
| "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. Receives: Procedure: "Trained Eye" (Angiography-Guided) LM PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 1 year follow-up
Secondary outcomes (1)
All individual components of DoCE at all time points.
Proportion of patients (%) achieving individual components of DoCE.
Measured: 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Jul 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Web-based randomization platform (Sealed Envelope), performed after eligibility confirmation and informed consent
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Conrady Alexandra, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711106
- Sponsor's protocol ID
- EYE-IVUS LM Trial
- Acronym
- EYE-IVUS LM
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographic, clinical, procedural and follow-up data. No personal data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "IVUS-Trained Eye" vs. Intravascular Ultrasound in Left Main Bifurcation Stenting: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT07711106
- Acronym / sponsor ID
- EYE-IVUS LM / EYE-IVUS LM Trial
- Conditions
- Coronary Artery Disease (CAD), Chronic Coronary Syndrome, Left Main Coronary Artery Disease, Coronary Bifurcation Lesion
- Keywords
- Intravascular ultrasound, Percutaneous coronary intervention, Left main, Bifurcation, IVUS-trained eye, Stent optimization, Minimal stent area
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of HealthUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Web-based randomization platform (Sealed Envelope), performed after eligibility confirmation and informed consent
| Arm | Type | Receives |
|---|---|---|
| IVUS-Guided Approach | Active comparator | Procedure: IVUS-Guided LM PCIPre-procedural IVUS will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent. |
| "Trained Eye" (Angiography-Guided) Approach | Experimental | Procedure: "Trained Eye" (Angiography-Guided) LM PCIStent sizing and procedural optimization guided by angiographic visual assessment and operator experience, with only IVUS assessment after intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVUS-Guided LM PCICoronary 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: * Baseline IVUS pullback - assessment of proximal and distal reference segments and lesion length * Stent selection based on IVUS data * Stent implantation * Mandatory optimization: kissing balloon dilation; proximal optimization * Final IVUS pullback to confirm result | Procedure or surgery | IVUS-Guided Approach |
| "Trained Eye" (Angiography-Guided) LM PCICoronary 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: * Anatomical assessment based on visual angiographic evaluation * Stent and balloon selection at operator discretion * Stent implantation * Mandatory optimization (same steps: kissing balloon dilation, proximal optimization) * Final IVUS pullback performed only afterward, solely to assess planimetric result (not used to guide the procedure itself) | Procedure or surgery | "Trained Eye" (Angiography-Guided) Approach |
Primary outcome
Relative optimal LM stent expansion
Time frame: Immediately post-procedure
Proportion of patients (%) achieving MSA ≥ 90% of the distal reference segment area according to IVUS, assessed after completion of all stenting and optimization steps
Absolute optimal LM stent expansion
Time frame: Immediately post-procedure
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
Device-oriented Composite Endpoint (DoCE)
Time frame: 1 year follow-up
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 secondary outcome
All individual components of DoCE at all time points.
Time frame: 1 year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: Yes. Demographic, clinical, procedural and follow-up data. No personal data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVUS-Guided LM PCI and "Trained Eye" (Angiography-Guided) LM PCI in people with Coronary Artery Disease (CAD) and Chronic Coronary Syndrome, run by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aleksei A. Prokhorikhin, PhD (+79137178040, aa.prohorihin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative optimal LM stent expansion (time frame: Immediately post-procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.