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New 3D imaging technique could replace pressure wire in heart artery procedures

NCT ID NCT04931771

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 trial tests whether a new 3D-imaging method called vFFR works as well as the standard pressure-wire technique (FFR) to guide treatment for narrowed heart arteries. About 2,200 adults with stable chest pain or a recent non-emergency heart attack will be randomly assigned to one of the two methods. The goal is to see if vFFR can safely determine which blockages need a stent, potentially avoiding the need for a pressure wire.

What this could mean

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

Active substance
vFFR (3D-angiography-based vessel fractional flow reserve) and FFR (fractional flow reserve) devices
What this could lead to
If vFFR works as well as FFR, it could simplify heart artery assessments by avoiding the need for a pressure wire, making the procedure faster and less invasive.
What could go wrong
This is a non-inferiority trial, meaning it aims to show vFFR is not worse than FFR, not that it is better. The results may not apply to all patients or settings.

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

2,235 people

The number who actually took part.

Started

Nov 2021

Finished

Dec 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. Presenting with silent ischemia, stable angina, or non-ST-elevation acute coronary syndrome (NSTE-ACS) 3. Coronary artery disease with at least one native artery in which the stenosis severity is questionable (typically 30-80% stenosis) 4. FFR assessment and vFFR assessment feasible 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: 1. ST-elevation myocardial infarction (STEMI) at presentation 2. Cardiogenic shock or severe hemodynamic instability at the time of intervention (heart rate\<50 beats per minute, systolic blood pressure \<90mmHg) or use of left ventricular assist device 3. Any target vessel with a distal Thrombolysis In Myocardial Infarction (TIMI) flow \<3. 4. Presence of thrombus in intermediate target lesion. 5. Known untreated severe valvular heart disease 6. Target lesion is located in or supplied by an arterial or venous bypass graft 7. History of cardiac allograft transplantation 8. Aorto-ostial lesions with an estimated diameter stenosis \>50% 9. Severe tortuosity precluding the acquisitions of 2 orthogonal projections of the target vessel with minimal overlap or foreshortening. 10. Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or adenosine 11. Non-cardiac co-morbidities with a life expectancy less than 1 year 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 until the trial primary endpoint time point is achieved and may only be enrolled once in the study 13. Women of childbearing potential who do not have a negative pregnancy test within 24 hours before the procedure 14. Subject belongs to a vulnerable population (per Investigator's judgment) or subject unable to read or write

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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.

Coronary artery disease

Contacts and locations

Locations

  • AOU di Ferrara (Ospedale Sant'Anna)

    Cona, Italy

  • Albert Schweitzer

    Dordrecht, Netherlands

  • Amphia Ziekenhuis

    Breda, Netherlands

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, Italy

  • CHU LILLE - Institut Cœur Poumon

    Lille, France

  • Cardiologia Ospedale Dell' Angelo

    Mestre, Italy

  • Cardiologia Ospedale San Bortolo

    Vicenza, Italy

  • Charité- Campus Benjamin Franklin

    Berlin, Germany

  • Clinique Saint Hilaire

    Rouen, France

  • Clinique St Martin

    Caen, France

  • Clinique les Fontaines

    Melun, France

  • Erasmus University Medical Center

    Rotterdam, Netherlands

  • Golden Jubilee National Hospital

    Glasgow, United Kingdom

  • Herz- und Diabeteszentrum NRW

    Bad Oeynhausen, Germany

  • Hospital Clinic

    Barcelona, Spain

  • Hospital Clinico Universitario de Valladolid

    Valladolid, Spain

  • Hospital Univeritario A Coruna

    A Coruña, Spain

  • Hospital Universitario Central de Asturias

    Oviedo, Spain

  • Hospital Universitario de Leon

    León, Spain

  • Hospital Universitario de la Princesa

    Madrid, Spain

  • Hospital del Mar

    Barcelona, Spain

  • Humanitas Research Hospital

    Milan, Italy

  • Hôpital Privé Jacques Cartier

    Massy, France

  • Hôpital de la Croix Rousse, hospices civils de lyon

    Lyon, France

  • Institut Cardiovasculaire de Grenoble

    Grenoble, France

  • John Radcliffe Hospital

    Oxford, United Kingdom

  • La Paz

    Madrid, Spain

  • Marienhaus Klinikum

    Neuwied, Germany

  • Mater Private Cork

    Cork, Ireland

  • Mater Private Dublin

    Dublin, Ireland

  • Ospedale Maggiore della Carità

    Novara, Italy

  • Pineta Grande Hospital

    Naples, Italy

  • Policlinico San Donato

    Milan, Italy

  • Royal Sussex County Hospital

    Brighton, United Kingdom

  • SHG Klinik Völklingen

    Völklingen, Germany

  • St James Hospital

    Dublin, Ireland

  • Tergooi MC

    Blaricum, Netherlands

  • UMCU

    Utrecht, Netherlands

  • Unfallkrankenhaus Berlin

    Berlin, Germany

  • Universitatsklinikum Dusseldorf

    Düsseldorf, Germany

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