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Double vision for heart stents: could two scans beat one?

NCT ID NCT05333068

Disease control Sponsor: Diagram B.V. 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two strategies for placing stents in people with multiple blocked heart arteries. One group gets standard guidance using a pressure wire (FFR), while the other also uses an imaging catheter (OCT) to spot unstable plaques. The goal is to see if the combined approach reduces deaths, heart attacks, and the need for more procedures over two years. About 1,200 adults aged 30-80 with at least two blockages are taking part.

What this could mean

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

Active substance
PCI revascularization strategy based on combined FFR and OCT assessment
What this could lead to
If successful, this approach could become a new standard for treating multiple blocked arteries, potentially lowering the risk of heart attacks and the need for repeat procedures.
What could go wrong
This is a large but still early-stage comparison; the combined strategy may not prove significantly better than standard care, and the added imaging could increase procedure time or cost without clear benefit.

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

1,223 people

The number who actually took part.

Started

Mar 2022

Expected to finish

Dec 2026

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

30 to 80 years

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. Patients undergoing PCI, aged 30-80 years with any clinical presentation 2. Angiographic criteria: presence of ≥ 2 de novo target lesions\* located in 2 different native coronary arteries feasible for treatment with PCI (operator / Heart team decision) Angiographic criteria target lesion\* (all criteria I-IV should be applicable): I. DS ≥ 50% on visual estimation II. de novo lesion located in native (non-grafted) vessel III. lesion reference diameter of ≥ 2.0 mm IV. Thrombolysis In Myocardial Infarction (TIMI) 3 flow in all vessels (with exclusion of culprit lesions if MI at presentation) \*Target lesions are either culprit MI lesions or lesions where FFR will be performed. Patients are eligible if they have ≥ 2 target lesions or one culprit and ≥ 1 target lesion. Exclusion Criteria: 1. Patients with MVD requiring coronary artery bypass grafting (CABG) treatment (operator / local heart team decision) 2. Lesion located in a grafted segment or in a vein graft 3. In-stent restenosis lesions 4. Left main trifurcation 5. Left main lesion stand-alone (without other lesions) 6. Patients with severe tortuous lesions (where FFR and OCT is judged impossible or dangerous) 7. Chronic total occlusion 8. Spontaneous coronary dissection 9. Patients with severe valvular heart disease likely to require cardiac surgery within the next 2 years 10. Patients with left ventricle (LV) function less than 30% 11. Renal insufficiency (Glomerular Filtration Rate (GFR) \< 29 ml/min/1.73m2; Kidney Disease Outcomes Quality Initiative (KDOQI) stage 4 and 5) 12. Life expectancy less than 3 years

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Conditions

The condition(s) this trial relates to.

coronary artery disorder ischemic disease

As listed by the trial registrant

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

Coronary artery disease Ischemia Multivessel coronary artery disease Vulnerable plaque

Contacts and locations

Locations

  • Aarhus University Hospital

    Aarhus, Denmark

  • Albert Schweitzer Hospital

    Dordrecht, Netherlands

  • Apex Heart Institute

    Ahmedabad, India

  • Apollo Hospitals

    Bangalore, India

  • C.C. Iliescu Institute of Cardiology Bucharest

    Bucharest, Romania

  • Centre Hospitalier Régional Universitaire de Lille

    Lille, France

  • Charité - Universitätsmedizin Berlin

    Berlin, Germany

  • Cheng Hsin General Hospital

    Taipei, Taiwan

  • Clinic Hospital Targu Mures & S.C. Cardio Med SRL

    Târgu Mureş, Romania

  • Clinique Louis Pasteur

    Nancy, France

  • Danderyd Hospital

    Stockholm, Sweden

  • Elisabeth-TweeSteden Hospital

    Tilburg, Netherlands

  • Far Eastern Memorial Hospital

    New Taipei City, Taiwan

  • Hamilton Health Sciences

    Hamilton, Canada

  • Hospital Bellvitge Barcelona

    Barcelona, Spain

  • Hospital Clinico San Carlos

    Madrid, Spain

  • Hospital Clínic de Barcelona

    Barcelona, Spain

  • Hospital Gregorio Marañón Madrid

    Madrid, Spain

  • Hospital La Fe Valencia

    Valencia, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, Spain

  • Hospital de La Princesa

    Madrid, Spain

  • Humanitas Research Hospital

    Milan, Italy

  • Jagiellonian University; John Paul II Hospital

    Krakow, Poland

  • Linköping University

    Linköping, Sweden

  • Lund University

    Lund, Sweden

  • Marqués de Valdecilla University Hospital

    Santander, Spain

  • McGill University Health Centre

    Montreal, Canada

  • Medical University of Silesia

    Katowice, Poland

  • Medisch Spectrum Twente

    Enschede, Netherlands

  • Middle Slovak Institute of Cardiovascular Disease

    Banská Bystrica, Slovakia

  • Miedziowe Centrum Zdrowia

    Lubin, Poland

  • Monash Medical

    Clayton, Australia

  • National Heart Institute

    Kuala Lumpur, Malaysia

  • National Taiwan University Hospital

    Taipei, Taiwan

  • National University Corporation Institute of Science Tokyo

    Bunkyō City, Japan

  • Niagara Health System - St. Catherines Site

    Saint Catharines, Canada

  • Nicolae Stăncioiu Heart Institute

    Cluj-Napoca, Romania

  • North-Estonia Medical Centre

    Tallinn, Estonia

  • OLVG

    Amsterdam, Netherlands

  • Policlinico Universitario Fondazione Agostino Gemelli

    Rome, Italy

  • Post Graduate Institute of Medical education and Research

    Chandigarh, India

  • Regional Specialist Hospital

    Wroclaw, Poland

  • Universitetssjukhuset Örebro

    Örebro, Sweden

  • University Hospital Krakow

    Krakow, Poland

  • University Hospital La Paz

    Madrid, Spain

  • Universitätsklinikum Frankfurt

    Frankfurt, Germany

  • Warsaw Medical University

    Warsaw, Poland

  • Wellington Hospital

    Wellington, New Zealand

  • Yokohama City University Medical Center

    Yokohama, Japan

More trials for these conditions

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