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Heart stent showdown: ultrasound guidance may beat standard X-Ray for major artery blockage

NCT ID NCT04111770

Disease control Sponsor: ECRI bv Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether using ultrasound inside the heart arteries (IVUS) to guide stent placement works better than standard X-ray guidance for people with a blockage in the left main coronary artery. About 800 patients were randomly assigned to one of the two methods and followed for up to 2 years. The goal was to see which approach reduces the risk of death, stroke, heart attack, or the need for another procedure.

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

806 people

The number who actually took part.

Started

Jul 2020

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: 1. The patient must be ≥ 18 years of age; 2. De novo lesion in an unprotected left main coronary artery (ULMCA; ostial, shaft or distal) OR ostial left anterior descending artery (LAD) or ostial circumflex (LCX), both compatible with one Medina class of LM disease; or ostial intermediate branch disease; 3. PCI is considered appropriate and feasible by the treating interventionalist; 4. Silent ischemia, stable angina, unstable angina, or non-ST segment elevation MI; 5. Able to understand and provide informed consent and comply with all study procedures, including follow-up for at least 2 years. Note: A patient with a prior CABG with no patent bypass on the left main coronary artery (LMCA) can be included. Exclusion Criteria: 1. Patient is a woman who is pregnant or nursing; 2. 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); 3. IVUS is strictly required for pre-PCI lesion severity assessment 4. ST-elevation myocardial infarction, cardiogenic shock; 5. Previous history of CABG with patent graft to the LAD and/or patent graft to the LCX; 6. Prior PCI of the LM, ostial LAD or ostial LCX at any time prior to enrollment; 7. Prior PCI of any other (i.e. non-LM, non-ostial-LAD and non-ostial-LCX) coronary artery lesions within 30 days prior to enrollment; 8. 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; 9. Known contraindication or hypersensitivity to everolimus, platinum-chromium, or to anticoagulants. 10. Patients requiring additional surgery (cardiac or non-cardiac) within 3 months post-enrollment; 11. Non-cardiac co-morbidities with a life expectancy less than 2 years; 12. Currently participating in another trial that is not yet at its primary endpoint. The patient is not allowed to participate in another investigational device or drug study for at least 12 months after enrollment.

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Conditions

The condition(s) this trial relates to.

coronary stenosis

As listed by the trial registrant

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

Left main coronary artery stenosis

Contacts and locations

Locations

  • A.O.U. di Ferrara

    Ferrara, Italy

  • AOUI Verona

    Verona, Italy

  • ASST Niguarda

    Milan, Italy

  • ASST Papa Giovanni XXIII

    Bergamo, Italy

  • Bristol Royal infirmary

    Bristol, United Kingdom

  • Golden Jubilee National Hospital

    Clydebank, United Kingdom

  • Hospital Alvaro Cunqueiro

    Vigo, Spain

  • Hospital Clinico Lozano Blesa

    Zaragoza, Spain

  • Hospital Clinico San Carlos

    Madrid, Spain

  • Hospital Clinico Universiatrio V. Arrixaca

    Murcia, Spain

  • Hospital Reina Sofia

    Córdoba, Spain

  • Hospital Universitario Marqués de Valdecilla

    Santander, Spain

  • Hospital Universitario de A Coruña

    A Coruña, Spain

  • Hospital Vall d´Hebron

    Barcelona, Spain

  • Hospital de Bellvitge

    Barcelona, Spain

  • Hospital de Cabueñes

    Gijón, Spain

  • Interventistica Cardiologica Strutturale

    Florence, Italy

  • John Radcliffe Hospital

    Oxford, United Kingdom

  • Leeds General Infirmary

    Leeds, United Kingdom

  • Policlinco San Donato

    Milan, Italy

  • Policlinico Umberto I

    Rome, Italy

  • Royal Bournemouth Hospital

    Bournemouth, United Kingdom

  • Royal Sussex Country Hospital

    Brighton, United Kingdom

  • Royal Victoria Hospital

    Belfast, United Kingdom

  • Sant'Ambrogio Clinical Institute

    Milan, Italy

  • St Bartholomew's Hospital

    London, United Kingdom

  • The Freeman Hospital

    Newcastle upon Tyne, United Kingdom

  • University Hospital of Wales

    Cardiff, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.