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Heart artery blockage study: stent or meds – which is better?

NCT ID NCT03563417

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 approaches for people with a completely blocked heart artery (chronic total occlusion) that is causing reduced blood flow to the heart muscle. One group will receive a stent to open the blockage, while the other will take medications only. The goal is to see which strategy better prevents major heart problems and improves quality of life. About 1,560 adults with stable heart disease are being enrolled.

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

About 1,560 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2018

Expected to finish

Nov 2032

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: * CTO in native coronary artery * Myocardial ischemia in a territory supplied by CTO assessed by nuclear imaging. * Age ≥18 yrs. * Able to provide written informed consent and willing to comply with the specified follow-up contacts. * Target artery ≥ 2.5 mm Prior to randomization all patients undergo 3 months of OMT. Subsequently the population will be divided into: Cohort A: Asymptomatic (CCS \< 2 and SAQ QoL \> 60) patients with myocardial ischemia (≥ 10% of LV) in a territory supplied by CTO Cohort B: Symptomatic patients (CCS class ≥ 2 and/or SAQ QoL score ≤ 60 after treating non CTO lesions and after OMT) with Myocardial ischemia (5% of LV) in a territory supplied a CTO assess by nuclear imaging. Cohort C: Screening population not eligible for randomization in cohort A or B Exclusion Criteria: * NSTEMI or STEMI within 1 month * Coronary anatomy not suitable for CTO-procedure * Coronary disease involving the left main/three vessel disease with indication for CABG following heart team conference. * Life expectancy \< 2 years * Severe chronic pulmonary disease (FEV1 \< 30 % of predicted value) * Contraindication to dual anti-platelet therapy * Pregnancy * eGFR \< 30 mL/min/1.73 m2 * In multi-vessel disease: if it is deemed unsafe to treat the non-CTO lesion first. * Severe valvular heart disease

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Conditions

The condition(s) this trial relates to.

myocardial ischemia

As listed by the trial registrant

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

Chronic total occlusion of coronary artery Ischemic heart disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aarhus University Hospital

    RECRUITING

    Aarhus N, 8200, Denmark

  • Barts Health NHS

    ACTIVE_NOT_RECRUITING

    London, SW17 0QT, United Kingdom

  • Belfast Health and Social Care Trust, Department of Cardiology

    ACTIVE_NOT_RECRUITING

    Belfast, BT9 7AB, United Kingdom

  • Cardiovascular Institute, Groupe Hospitalier Mutualiste

    RECRUITING

    Grenoble, 38000, France

  • Clinique Louis Pasteur

    ACTIVE_NOT_RECRUITING

    Essey-lès-Nancy, 54270, France

  • Gentofte Hospital

    RECRUITING

    Hellerup, 2900, Denmark

  • Heart Hospital Tampere

    RECRUITING

    Tampere, 33520, Finland

  • Helsinki University Central Hospital

    ACTIVE_NOT_RECRUITING

    Helsinki, 00029, Finland

  • Hospital Clinic

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital Galdakao

    RECRUITING

    Galdakao, Bizkaia, 48960, Spain

  • Hospital Germans Trias I Pujol

    ACTIVE_NOT_RECRUITING

    Badalona, Barcelona, 08916, Spain

  • Hospital Universitari de Tarragona Joan XXIII

    RECRUITING

    Tarragona, 43005, Spain

  • Hospital Universitario Clinico San Carlos

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Vall de Hebron

    ACTIVE_NOT_RECRUITING

    Barcelona, 08035, Spain

  • Hospital de Bellvitge

    ACTIVE_NOT_RECRUITING

    Barcelona, 08907, Spain

  • Hospital la Paz

    ACTIVE_NOT_RECRUITING

    Madrid, 28046, Spain

  • Kuopio University Hospital

    ACTIVE_NOT_RECRUITING

    Kuopio, 70210, Finland

  • North-Estonia Medical Centre

    RECRUITING

    Tallinn, 13419, Estonia

  • Odense University Hospital

    RECRUITING

    Odense, 5000, Denmark

  • Rigshospitalet

    RECRUITING

    Copenhagen, 2100, Denmark

  • Sahlgrenska University Hospital

    RECRUITING

    Gothenburg, 41345, Sweden

  • Skaane University Hospital (Lund)

    ACTIVE_NOT_RECRUITING

    Lund, 22185, Sweden

  • St George's University Hospital

    ACTIVE_NOT_RECRUITING

    London, SW17 0QT, United Kingdom

  • Stockholm South Central Hospital (Södersjukhuset)

    ACTIVE_NOT_RECRUITING

    Stockholm, 11883, Sweden

  • Turku University Hospital

    RECRUITING

    Turku, 20521, Finland

  • University Hospital Bristol

    ACTIVE_NOT_RECRUITING

    Bristol, BS1 3NU, United Kingdom

  • Zealand University Hospital

    RECRUITING

    Roskilde, 4000, Denmark

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