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New stent combo could shorten blood thinner use for major heart artery blockage

NCT ID NCT05650411

Disease control Sponsor: IGLESIAS Juan Fernando Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 trial tests a new type of stent (Supraflex Cruz) combined with a shorter course of blood thinners (only 1-3 months of dual therapy, then just one drug) for people with a blockage in the left main coronary artery. The goal is to see if this approach reduces bleeding risks while still preventing heart attacks and keeping the artery open. About 828 participants will be followed for two years.

What this could mean

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

Active substance
Supraflex Cruz stent (drug-eluting stent with sirolimus) and P2Y12 inhibitor (ticagrelor or prasugrel) single antiplatelet therapy
What this could lead to
If successful, this could offer a safer, effective way to treat left main coronary artery disease with a shorter course of blood thinners, reducing bleeding risks.
What could go wrong
This is an early-stage trial with no phase designation, and the strategy has not been tested in this high-risk group before. There is a risk of heart attack or stent blockage despite the new approach.

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 828 people

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

Started

Apr 2026

Expected to finish

May 2032

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 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: * Age ≥18 years. * Patient with chronic or acute coronary syndrome (unstable angina, or non-ST-elevation acute coronary syndrome). * Subject with significant unprotected (ostial, mid-shaft, or distal) LMCA stenosis who underwent successful LMCA PCI with ≥1 Supraflex Cruz ultrathin-strut biodegradable polymer sirolimus-eluting stent (Sahajanand Medical Technologies Ltd., Surat, India) according to current ESC guidelines on myocardial revascularization and/or local Heart Team decision. * Subject willing to participate and able to understand, read and sign the informed consent document before the planned procedure. Exclusion Criteria: * Contraindications to PCI and/or DES implantation. * Inability to adhere to DAPT for at least 6 months. * Patient already on DAPT. * Patients on oral anticoagulation. * Previous coronary artery bypass surgery. * LMCA in-stent restenosis or stent thrombosis. * Recent ST-elevation myocardial infarction \<5 days prior to randomization. * Cardiogenic shock/hemodynamic instability at the time of intervention and/or need for mechanical/pharmacologic hemodynamic support. * Participation or planned participation in another clinical trial, except for observational registries. * Life expectancy \<1 year. * Pregnancy.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder coronary stenosis

As listed by the trial registrant

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

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 places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Zurich University Hospital

    RECRUITING

    Zurich, Canton of Zurich, Switzerland

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