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New heart artery treatment could save millions: hybrid strategy tested against standard stenting

NCT ID NCT07159737

Disease control Sponsor: Hospital Sultanah Bahiyah Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests if a new hybrid approach—using one stent plus a drug-coated balloon—works better than the usual two-stent method for treating a severe blockage in the left main coronary artery. About 800 adults with this condition will be randomly assigned to one of the two treatments. The goal is to see which method better prevents death, heart attacks, and the need for repeat procedures over two years.

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 800 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

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: Floating eligibility criteria * De novo unprotected true left main bifurcation (UTLMB) (Medina 1,1,1; 1,0,1; and 0,1,1). * Optimal LCx lesion preparation (residual stenosis less than 30% with absence of flow-limiting dissection). * The operator feels it might be appropriate to place either a drug-eluting stent (DES) or drug-coated balloon (DCB) to the LCX * Clinically stable at the time of randomisation. * Able to complete 2-year follow-up. * Able to complete dual antiplatelet therapy (DAPT) as per guidelines. * Written informed consent (or verbal consent on-table with written consent as soon as possible thereafter). Exclusion Criteria: * Protected left main (patent graft to LAD and LCX) * Need for anticoagulation * LCx reference vessel diameter less than 2.5 mm (\< 2.5 mm) * Cardiogenic shock * Severe left ventricular (LV) dysfunction making either strategy unsafe * Contraindication to antiplatelet therapy or study devices * Life expectancy less than 2 years * Participation in another trial that may affect results

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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.

Unprotected left main coronary artery disease

How to take part

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

  1. 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 ↗

  2. 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.