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New heart stent strategy tested for tough blockages

NCT ID NCT07408674

Disease control Sponsor: Rede Optimus Hospitalar SA 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests if using a drug-coated balloon along with a stent works better than a stent alone for people with complex blockages in the left main coronary artery. About 186 adults with this condition will be randomly assigned to one of two treatments. The goal is to see which approach keeps the artery more open over time.

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 186 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

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: 1. Distal left main stem bifurcation stenosis type Medina 1,1,1 or 0,1,1 with indication for revascularization. 2. Left main diameter ≤6.00 mm. 3. LAD and LCx diameter both \>2.75 mm, evaluated by visual estimation. Exclusion Criteria: 1. Subjects with ages 18 or below at the time of the procedure. 2. Female subjects who may be pregnant or breast-feeding at the time of the procedure. 3. Previous PCI of the left main bifurcation. 4. Chronic total occlusion of the LAD or LCx. 5. Trifurcating left main requiring treatment of the 3 branches. 6. LAD and LCx reference sizes are out of the sizing ranges of the used DES/DCB families. 7. In-stent restenosis as target lesion. 8. Previous coronary artery bypass graft (CABG) with any patent graft on the left coronary system. 9. ACS-STEMI (ST-Segment Elevation Myocardial Infarction) due to LM disease. 10. Cardiogenic shock. 11. Left ventricular ejection fraction below 35%. 12. Decision to use mechanical circulatory support for protected PCI. 13. Contraindication to a minimum of 3 months double antiplatelet and long-term single antiplatelet therapy (or adapted, in case of indication for anticoagulation). 14. Associated significant valvular disease. 15. Renal insufficiency with glomerular filtration rate (GFR) \< 20. 16. Life expectancy less than one year.

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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.

Complex left main bifurcation stenosis Coronary bifurcation stenosis Left main coronary artery stenosis

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.

More trials for these conditions

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