New heart surgery combo could spare patients from open chest incision

NCT ID NCT05504031

Disease control Sponsor: Rigshospitalet, Denmark Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will compare a newer, less invasive heart procedure called hybrid revascularization to standard coronary artery bypass grafting (CABG) in over 1,000 people with multiple blocked heart arteries. The hybrid approach combines a small incision to graft a key artery with stents to open other blockages, avoiding a full chest opening. The goal is to see if it is as safe and effective as traditional bypass surgery in preventing death, heart attacks, strokes, and hospital stays.

What this could mean

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

Active substance: Hybrid coronary revascularization (minimally invasive heart surgery combined with stenting)
What this could lead to: If successful, this could offer a less invasive alternative to open-heart bypass surgery for people with multiple blocked heart arteries, potentially leading to faster recovery and fewer complications.
What could go wrong: This is a large, well-designed trial, but it hasn't started yet. The hybrid approach is complex and may not prove as durable or safe as standard bypass surgery over the long term. There are also risks of bleeding, infection, and heart attack with both 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

About 1,048 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jan 2044

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 to 80 years

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: * Written informed consent * ≥ 18 years of age * Functionally significant MVD, defined as ≥ 70% diameter stenosis by visual estimation or functionally significant stenosis (FFR \< 0.80, non-hyperaemic index (iFR) \< 0.89) in at least two of the major epicardial vessels or major side branches * Patient history reviewed by both cardiac surgeon and cardiologist who in agreement find both CABG and hybrid revascularisation indicated and technically feasible with an expectation of complete revascularisation of all functionally significant stenoses in the LAD and at least one other coronary artery ≥ 2.5mm in diameter or left main bifurcation stenosis with functionally significant stenoses in both the LAD and left circumflex artery. Exclusion Criteria: * Chronic kidney disease with estimated glomerular filtration rate \< 20 mL/min/kg * Pregnancy * Left main stenosis without additional functionally significant stenoses in both the LAD and the LCX * Contraindications to the use of dual antiplatelet therapy * STEMI within 1 month * Indication for acute revascularization

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

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

Coronary artery disease

How to take part

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

The places running it

3 sites in 3 countries. The list below names each one and where it is.
The official record

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

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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.

New heart surgery combo could spare patients from open chest incision

What the study statuses mean