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Heart showdown: stenting may rival bypass surgery in emergency patients

NCT ID NCT01311323

Disease control Sponsor: American Heart of Poland 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 09, 2026 · Updated 3 times

Summary

This study compares two treatments for people with severe blockages in multiple heart arteries who are having a heart attack without ST elevation. One treatment is stenting (a tube to open arteries), the other is bypass surgery (rerouting blood flow). The goal is to see if stenting is as safe and effective as surgery in preventing death, heart attack, stroke, or heart failure within a year. The trial plans to enroll 1000 participants.

What this could mean

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

Active substance
Percutaneous coronary intervention (stenting) and coronary artery bypass graft surgery
What this could lead to
If stenting proves as good as bypass surgery, more patients with severe heart disease could avoid open-heart surgery and recover faster.
What could go wrong
This is a large trial, but earlier studies mainly included stable patients. The results may not apply to all, and stenting carries risks like re-narrowing of arteries.

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 1,000 people

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

Started

Aug 2025

Expected to finish

Nov 2030

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: Subjects must meet ALL of the inclusion criteria to be considered for the trial. If ANY of the exclusion criteria are met, the subject is excluded from the trial and cannot be randomized. * Age over 18 years, * Written patient consent, * Acute Coronary Syndrome without ST-segment elevation of high, intermediate and low risk, including NSTEMI and unstable angina requiring urgent (within 72 hours) invasive strategy, * Qualification for invasive treatment, * Multivessel coronary disease, defined as angiographic narrowing \>50%DS on investigator's visual assessment in at least two major coronary artery territories (RCA, LAD, LCX), including involvement of the proximal segment of the left anterior descending artery or three-vessel disease with a Syntax Score \< 33. Intermediate lesions (40-70%) will need to be assessed with either FFR, iFR, or VFFR). Patient may have left main coronary artery disease, defined as narrowing \>50%DS (but this is not obligatory). For borderline changes, IVUS (MLA \<6 mm2 or iFR=\<0,90 or FFR=\<0,80, with an anatomic Syntax Score \<33 will be decisive, * Feasibility of complete revascularization on both the CABG and PCI sides, * Consent within the Heart Team for both CABG by the cardiothoracic surgeon and PCI by the interventional cardiologist. Exclusion Criteria: * Age under 18 years, * ST-segment elevation myocardial infarction (STEMI) or new left bundle branch block (LBBB), * Stable coronary syndrome, * Single- or two-vessel coronary disease without involvement of the proximal LAD, defined as narrowing above 50%DS, * Qualification for conservative treatment, * Anticipated surgery other than CABG due to severe valvular defect or other structural defect, particularly moderate or severe mitral regurgitation, * Need for immediate coronary angioplasty treatment, * Syntax Score equal or above 33 (\>=33), * Contraindications to short-term and long-term antiplatelet therapy, * Acute heart failure in class IV (cardiogenic shock), * Previous CABG procedure, * Previous PCI procedure within the last 6 months, * Ischemic or hemorrhagic stroke within 6 months prior to inclusion, * End-stage chronic kidney disease on dialysis, * Pregnancy or intention to become pregnant (women of child bearing age must have a recent negative pregnancy test prior to randomization), * Non cardiac co-morbidities with life expectancy less than 3 years, * Participation in other clinical trial that have not reached their primary endpoint.

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome coronary artery disorder

As listed by the trial registrant

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

Acute coronary syndrome Multivessel coronary artery disease

How to take part

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

  1. The places running it

    9 sites. 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

  • Małopolska Cardiovascular Center, Polish-American Heart Clinic in Chrzanów

    RECRUITING

    Chrzanów, Malopolska, 32-500, Poland

  • National Medical Institute of the Ministry of the Interior and Administration

    RECRUITING

    Warsaw, Poland

  • Polish-American Heart Clinics Cardiovascular Center in Kędzierzyn-Koźle

    RECRUITING

    Kędzierzyn-Koźle, Poland

  • Polish-American Heart Clinics Center for Cardiology and Cardiac Surgery Outpatient Specialist Care in Bielsko-Biała

    RECRUITING

    Bielsko-Biala, Silesian Voivodeship, 43-316, Poland

  • Polish-American Heart Clinics III Department of Invasive Cardiology, Angiology and Electrocardiology

    RECRUITING

    Dąbrowa Górnicza, Silesian Voivodeship, 41-300, Poland

  • Polish-American Heart Clinics X Department of Invasive Cardiology, Electrophysiology and Electrostimulation in Tychy

    RECRUITING

    Tychy, 43-100, Poland

  • Polish-American Heart Clinics, 1st Department of Cardiology and Angiology in Ustroń

    RECRUITING

    Ustroń, Silesian Voivodeship, 43-450, Poland

  • University Clinical Hospital in Opole

    RECRUITING

    Opole, Poland

  • Upper Silesian Medical Center in Katowice

    RECRUITING

    Katowice, Poland

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