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Heart showdown: stents vs. bypass surgery in major trial

NCT ID NCT02100722

Disease control Sponsor: Stanford University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study looked at 1,500 people with severe blockages in three heart arteries. It compared a less invasive procedure using a pressure wire to guide stent placement (FFR-guided PCI) with open-heart bypass surgery (CABG). The goal was to see if the stent approach could match the surgery's results in preventing death, heart attacks, strokes, 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

1,500 people

The number who actually took part.

Started

Aug 2014

Finished

Dec 2024

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

21 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\. Age ≥ 21 years with angina and/or evidence of myocardial ischemia * 2\. Three vessel CAD, defined as ≥ 50% diameter stenosis by visual estimation in each of the three major epicardial vessels or major side branches, but not involving left main coronary artery, and amenable to revascularization by both PCI and CABG as determined by the Heart Team. Patients with a non-dominant right coronary artery may be included if only the left anterior descending artery (LAD) and left circumflex have ≥50% stenosis * 3\. Willing and able to provide informed, written consent Exclusion Criteria: * 1\. Requirement for other cardiac or non-cardiac surgical procedure (e.g., valve replacement, carotid revascularization) * 2\. Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support * 3\. Recent STEMI (\<5 days prior to randomization) * 4\. Ongoing Non STEMI with biomarkers (cardiac troponin) still rising * 5\. Known left ventricular ejection fraction \<30% * 6\. Life expectancy \< 2 years * 7\. Requiring renal replacement therapy * 8\. Undergoing evaluation for organ transplantation * 9\. Participation or planned participation in another clinical trial, except for observational registries * 10\. Pregnancy * 11\. Inability to take dual antiplatelet therapy for six months * 12\. Previous CABG * 13\. Left main disease requiring revascularization * 14\. Extremely calcified or tortuous vessels precluding FFR measurement * 15\. Any target lesion with in-stent drug-eluting stent restenosis

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Conditions

The condition(s) this trial relates to.

coronary artery disorder Coronary Disease coronary stenosis

As listed by the trial registrant

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

Coronary disease Coronary stenosis

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, South Korea

  • Atlanta VA Medical Center

    Decatur, Georgia, United States

  • Baystate Medical Center

    Springfield, Massachusetts, United States

  • Cardiovascular Center Aalst

    Aalst, 9300 Aalst, Belgium

  • Cardiovascular Hospital

    Lyon, France

  • Catharina Hospital Eindhoven

    Eindhoven, 5623 EJ, Netherlands

  • Centennial Heart

    Nashville, Tennessee, United States

  • Clinical Center Kragujevac

    Kragujevac, Serbia

  • Concord Hospital

    Sydney, Australia

  • Danderyds Sjukhus

    Stockholm, Sweden

  • Golden Jubilee National Hospital

    Glasgow, United Kingdom

  • HagaZiekenhuis

    The Hague, Netherlands

  • HealthEast St. Joseph's Hospital

    Saint Paul, Minnesota, United States

  • Houston Methodist Hospital

    Houston, Texas, United States

  • Hungarian Institute of Cardiology

    Budapest, Hungary

  • Isala Klinieken

    Zwolle, Netherlands

  • Jesse Brown VA Medical Center

    Chicago, Illinois, United States

  • Karolinska Institutet, Dep of clinical science and education, Södersjukhuset

    Stockholm, Sweden

  • Kings College Hospital

    London, United Kingdom

  • Le'Centre Hospitalier de l'Universite de Montreal

    Montreal, Canada

  • Lexinton VA

    Lexington, Kentucky, United States

  • Masaryk University and University Hospital Brno

    Brno, Czechia

  • Oxford University Hospital NHS Trust

    Oxford, United Kingdom

  • Palo Alto VA

    Palo Alto, California, United States

  • Peninsula Health

    Frankston, Australia

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, United States

  • Rigshospitalet University Hospital

    Copenhagen, Denmark

  • Royal North Shore

    Sydney, Australia

  • Sahlgrenska University Hospital

    Gothenburg, Sweden

  • Southampton University Hospitals NHS Trust

    Southhampton, United Kingdom

  • St. Thomas' Hospital

    London, United Kingdom

  • St. Vincent's Hospital Melbourne

    Melbourne, Australia

  • Stanford University

    Stanford, California, 94305-2004, United States

  • Stavanger University Hospital

    Stavanger, Norway

  • University Clinical Center of Serbia

    Belgrade, Serbia

  • University Hospitals Coventry and Warwickshire

    Coventry and Warwickshire, United Kingdom

  • University of Kansas Medical Center

    Lawrence, Kansas, United States

  • University of Kentucky Medical Center

    Lexington, Kentucky, United States

  • University of Ottawa Heart Institute

    Ottawa, Canada

  • University of Sydney

    Sydney, Australia

  • University of Virginia

    Charlottesville, Virginia, United States

  • Vilnius University Hospital Santariskiu Klinikos

    Vilnius, Lithuania

  • Waikato Hospital

    Hamilton, New Zealand

  • Wales Heart Research Institute

    Cardiff, United Kingdom

  • Wythenshawe Hospital

    Manchester, United Kingdom

  • York PCI Group INC

    Ontario, Canada

More trials for these conditions

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