Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Sound waves may make heart stenting safer for High-Risk patients

NCT ID NCT04854070

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares two ways to guide heart stenting in people with complex coronary artery disease: using an ultrasound probe inside the artery (IVUS) versus standard X-ray guidance (angiography). About 2,020 patients with tough-to-treat blockages were randomly assigned to one method. The goal is to see if IVUS reduces the chance of heart-related death, heart attack, or the need for repeat procedures.

What this could mean

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

Active substance
Intravascular ultrasound (IVUS) device
What this could lead to
If IVUS guidance proves superior, it could become the new standard for complex heart stenting, reducing deaths and heart attacks.
What could go wrong
This is a post-marketing study, not a new drug; the benefit may be small or not apply to all patients. The results are still being analyzed.

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

2,020 people

The number who actually took part.

Started

Nov 2021

Finished

Aug 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: All of the following: 1. The patient must be ≥18 years of age 2. Patients with an indication for PCI of at least one lesion satisfying any of the following criteria: 1. Angiographic heavy calcification 2. Ostial lesions 3. True bifurcation lesions involving side-branches \>2.5mm 4. Left main lesions 5. Chronic total occlusion 6. In-stent restenosis 7. Long-lesions (estimated stent length \> 28mm) OR Patient with an indication for PCI for any lesion and in need for elective mechanical circulatory support assisted PCI 3. Presenting with silent ischemia, stable angina, unstable angina or non-ST-elevation acute coronary syndrome (NSTE-ACS) 4. All lesions must be suitable for treatment with the Synergy stent system, Synergy Megatron system, or other Synergy platform iteration 5. The patient is willing and able to cooperate with study procedures and follow-up until study completion 6. Subject is able to confirm understanding of risks, benefits and treatment alternatives and he/she provides informed consent prior to any protocol-related procedure, as approved by the appropriate Ethics Committee Exclusion Criteria: Any of the following: 1. ST-elevation myocardial infarction, cardiogenic shock 2. Known untreated severe valvular heart disease 3. IVUS is strictly required for pre-PCI lesion severity assessment 4. Requiring PCI in a diseased aorto-coronary bypass 5. Known contraindication or hypersensitivity to everolimus, platinum-chromium, or to anticoagulants 6. Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to antiplatelet drugs, including both aspirin and P2Y12 inhibitors 7. Non-cardiac co-morbidities with a life expectancy less than 1 year 8. 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 until the trial primary endpoint time point is achieved and may only be enrolled once in the study 9. Women of childbearing potential who do not have a negative pregnancy test within 7 days before the procedure and women who are breastfeeding 10. Subject belongs to a vulnerable population (per investigator's judgment) or subject unable to read or write

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Complex coronary lesions are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

As listed by the trial registrant

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

Complex coronary lesions

Contacts and locations

Locations

  • Albert Schweitzer hospital

    Dordrecht, Netherlands

  • Bellvitge University Hospital

    Barcelona, Spain

  • CHRU Tours - HopitalTrousseau

    Tours, France

  • CHU

    Charleroi, Belgium

  • CHU

    Toulouse, France

  • Cardiovascular Institute of Grenoble, GHM

    Grenoble, France

  • Catharina hospital

    Eindhoven, Netherlands

  • Centre Cardiologique du Nord Saint-Denis

    Saint-Denis, France

  • Charite Universitatsmedizin Berlin

    Berlin, Germany

  • Clinique Pasteur

    Toulouse, France

  • Clinique Saint-Augustin

    Bordeaux, France

  • Erasmus University Medical Center

    Rotterdam, Netherlands

  • Golden Jubilee National Hospital

    Glasgow, United Kingdom

  • Heart Center Dresden

    Dresden, Germany

  • Hopital Privé Jacques Cartier

    Massy, France

  • Hospital Clinic de Barcelona

    Barcelona, Spain

  • Hospital la Paz

    Madrid, Spain

  • Humanitas Research Hospital

    Milan, Italy

  • John Radcliffe Hospital

    Oxford, United Kingdom

  • La Princesa University Hospital

    Madrid, Spain

  • Marques de Valdecilla University Hospital

    Santander, Spain

  • MediClin Heartcenter Lahr

    Lahr, Germany

  • Noordwest Hospital Group

    Alkmaar, Netherlands

  • OLVZ

    Aalst, Belgium

  • Ospedale degli infermi di Rivoli

    Rivoli, Italy

  • Ospedale dell'Angelo

    Venezia, Italy

  • Reina Sofia Hospital

    Córdoba, Spain

  • Royal Victoria Hospital

    Belfast, United Kingdom

  • Segeberger Kliniken

    Bad Segeberg, Germany

  • St. George's University Hospital

    London, United Kingdom

  • University Clinical Hospital of Valladolid

    Valladolid, Spain

  • University Hospital Gasthuisberg

    Leuven, Belgium

  • University of Ferrara

    Ferrara, Italy

  • University of Giessen

    Giessen, Germany

  • Universitätsklinikum Frankfurt

    Frankfurt, Germany

  • VuMC

    Amsterdam, Netherlands

  • ZOL Sint-Jan

    Genk, Belgium

More trials for these conditions

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