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Stents or bypass? 10-Year study aims to settle the debate for heart patients

NCT ID NCT07308860

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 follows 1,500 patients with multivessel coronary artery disease who were randomly assigned to receive either coronary stenting guided by fractional flow reserve or coronary bypass surgery. Researchers will compare survival, quality of life, and chest pain relief over 10 years to determine which approach offers better long-term outcomes.

What this could mean

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

What this could lead to
If successful, this could help doctors choose the best long-term treatment for patients with multiple blocked heart arteries.
What could go wrong
This is an observational follow-up, not a new treatment test. Results may not apply to all patients, and individual risks like complications from either procedure remain.

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.

Participants

1,500 people

The number who actually took part.

Started

Aug 2025

Expected to finish

Jun 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.

Who is studied

This study will evaluate outcomes, including death and quality of life, at 10 years in 1,500 patients with coronary disease who have already been randomized to either bypass surgery or stenting.

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), however a maze procedure or pulmonary vein isolation is allowed 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 or anticoagulation and single antiplatelet therapy for at least 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 16. More than one major epicardial vessel which is chronically occluded

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Conditions

The condition(s) this trial relates to.

Angina Pectoris coronary artery disorder Death myocardial infarction stroke disorder

As listed by the trial registrant

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

Coronary artery disease

Contacts and locations

Locations

  • Stanford University

    Stanford, California, 94305, United States

More trials for these conditions

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