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Can a trained eye match ultrasound for heart stent placement?

NCT ID NCT07711106

Disease control Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This trial tests whether an experienced doctor's eye, guided by standard X-ray images, can place a heart stent as well as using a special ultrasound probe inside the artery. The study focuses on the left main coronary artery, a critical vessel. All patients receive the same type of stent, and the goal is to see if the stent expands properly to restore blood flow.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Coronary stent implantation guided by either intravascular ultrasound (IVUS) or angiographic assessment with operator experience
What this could lead to
If successful, this could show that experienced operators using angiography alone can achieve stent expansion as good as with IVUS guidance, potentially simplifying procedures.
What could go wrong
This is a small, early-phase trial with only 50 participants, so results may not apply broadly. The comparison relies heavily on operator skill, which varies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic coronary syndrome Coronary artery disease (CAD) Coronary bifurcation lesion Left main coronary artery disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Saint Petersburg, Russia

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