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New imaging technique could improve stent outcomes in heart patients

NCT ID NCT03171311

Disease control Sponsor: Aarhus University Hospital Skejby 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether using a special imaging tool called OCT during stent placement leads to fewer heart problems over two years compared to standard methods. About 1,200 adults with blocked heart arteries that need complex stenting are taking part. The goal is to see if OCT guidance reduces the risk of heart-related death, heart attacks, or the need for repeat procedures.

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

1,201 people

The number who actually took part.

Started

Jul 2017

Expected to finish

May 2029

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: * Stable angina pectoris, unstable angina pectoris, clinically stable non-STEMI. * Age ≥18 yrs. * Abel to provide written Informed consent and willing to comply with the specified follow-up contacts. Angiographic inclusion criteria: * Native coronary bifurcation de novo lesion * More than 50% diameter stenosis in the main vessel (MV) * More than 50% diameter stenosis in the side branch (SB) within 5 mm of the ostium. * Reference size at least 2.75 mm in the main vessel (MV) and ≥2.5 mm in the SB. Functional inclusion criteria: Functional significance of the main vessel lesion or documented ischemia of the main vessel territory or other objective documentation of lesion significance. Objective evidence of ischemia is required for all treated lesions except for lesions with more than 80% diameter stenosis that may be considered significant. Procedural inclusion criteria: Indication for two-stent technique or one-stent technique with kissing balloon inflation Exclusion Criteria: * STEMI within 72 hours * Cardiogenic shock * Prior coronary artery bypass grafting (CABG) or planned CABG * Renal failure with glomerular filtration rate (GFR) \<50 mL/min per 1.73 m2 * Active bleeding or coagulopathy * Life expectancy \< 2 years * Ejection fraction \< 30% * New York Heart Association (NYHA) class \> II * Relevant allergies (aspirin, clopidogrel, ticagrelor, contrast compounds, everolimus). Angiographic exclusion criteria: * Severe tortuosity around target bifurcation * Chronic total occlusions * Massive thrombus in Left main coronary artery * Medina 0.0.1 lesions

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Conditions

The condition(s) this trial relates to.

coronary artery disorder myocardial ischemia

As listed by the trial registrant

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

Ischaemic heart disease Ischemic heart disease

Contacts and locations

Locations

  • Aalborg University Hospital

    Aalborg, 9100, Denmark

  • Aarhus University Hospital Skejby

    Aarhus N, 8200, Denmark

  • Azienda Ospedaliero-Universitaria di Ferrara

    Ferrara, Cona, 44124, Italy

  • Belfast Health and Social Care Trust

    Belfast, BT9 7AB, United Kingdom

  • Cardiologicum Hamburg

    Hamburg, 22041, Germany

  • Estonia Medical Centre

    Tallinn, 13419, Estonia

  • Gemelli General Hospital, Catholic University of the Sacred Heart

    Rome, 00168, Italy

  • Gentofte Hospital

    Gentofte Municipality, 2820, Denmark

  • Golden Jubilee Hospital

    Glasgow, G81 4DY, United Kingdom

  • Haukeland University Hospital, Bergen

    Bergen, Norway

  • Hospital of Southern Norway, Arendal

    Arendal, 4604, Norway

  • Karolinska University Hospital Huddinge

    Huddinge, Stockholm County, 14157, Sweden

  • Latvia Centre of Cardiology

    Riga, LV-1002, Latvia

  • Leuven University Hospital

    Leuven, 3000, Belgium

  • Medical University of Warsaw

    Warsaw, 02-097, Poland

  • Morriston Hospital

    Swansea, SA6 6NL, United Kingdom

  • Northwest Hospital Alkmaar

    Alkmaar, 1815, Netherlands

  • Odense University Hospital

    Odense, 5000, Denmark

  • Oslo University Hospital - Ullevål

    Oslo, 0450, Norway

  • Oslo University Hospital, Rikshospitalet

    Oslo, 0424, Norway

  • Rigshospitalet

    København Ø, 2100, Denmark

  • Royal Bournemouth Hospital

    Bournemouth, BH77DW, United Kingdom

  • Sahlgrenska University Hospital

    Gothenburg, 413 45, Sweden

  • St Antonius Ziekenhuis

    Nieuwegein, 3435 CM, Netherlands

  • St George's Hospital

    London, SW17 0QT, United Kingdom

  • Sussex Cardiac Centre

    Brighton, BN2 5BE, United Kingdom

  • Södersjukhuset

    Stockholm, 118 83, Sweden

  • Tampere University Hospital

    Tampere, 33520, Finland

  • Trondheim University Hospital

    Trondheim, Norway

  • University Hospital Galway

    Galway, H91YR71, Ireland

  • University Hospital South Manchester, Wythenshawe Hospital

    Manchester, M239LT, United Kingdom

  • Universitäres Herzzentrum Hamburg

    Hamburg, 20246, Germany

  • Universitätsklinikum Schleswig-Holstein Campus Kiel

    Kiel, 24105, Germany

  • VU University Medical Center (VUMC)

    Amsterdam, 1081 HV, Netherlands

  • Vivantes Klinikum im Friedrichshain

    Berlin, State of Berlin, 10249, Germany

  • Zealand University Hospital, Roskilde Sygehus

    Roskilde, 4000, Denmark

  • Ziekenhuis Oost-Limburg (ZOL) Genk

    Genk, 3600, Belgium

  • Örebro University Hospital

    Örebro, 70185, Sweden

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