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Balloon vs stent: new hope for heart patients with multiple blockages?

NCT ID NCT07539324

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a drug-coated balloon is as good as or better than a drug-eluting stent for people with multiple blocked heart arteries. About 892 adults with stable heart disease or recent heart attack will be randomly assigned to one of the two treatments. The goal is to see which approach leads to fewer deaths, heart attacks, repeat procedures, or bleeding events.

What this could mean

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

Active substance
Paclitaxel-coated balloon catheter
What this could lead to
If successful, this could offer a stent-free option for treating multiple blocked heart arteries, potentially reducing long-term complications like bleeding.
What could go wrong
This is an early-stage trial not yet recruiting, and the balloon approach may not be as effective as stents for keeping arteries open long-term.

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 892 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

Jul 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 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. Male or female adults aged 20 years or older with stable angina, silent myocardial ischemia, unstable angina, or non-ST-segment elevation myocardial infarction (NSTEMI). 2. In cases of ST-segment elevation myocardial infarction (STEMI), patients who have undergone successful primary percutaneous coronary intervention (PCI) without complications, at least 48 hours post-procedure, and whose target lesion(s) show no evidence of thrombus. 3. Patients with multivessel coronary artery disease, defined as angiographic stenosis of 50% in at least two major epicardial coronary arteries requiring PCI as determined by the investigator. 4. Reference vessel diameter (RVD) of the target lesion(s) between 2.25 mm and 4.0 mm by visual estimation or quantitative coronary angiography (QCA). 5. Target lesions suitable for treatment with either drug-eluting stents (DES) or drug-coated balloons (DCB). 6. Patients who have voluntarily provided written informed consent and are willing and able to comply with all protocol-specified requirements. Exclusion Criteria: 1. Cardiogenic shock or patients requiring mechanical or pharmacological circulatory support. 2. Patients with a life expectancy of less than 2 years due to comorbid conditions. 3. Patients who are currently participating or planning to participate in other interventional clinical trials, excluding observational studies. 4. Women who are pregnant or have childbearing potential. 5. Patients with a known hypersensitivity or allergy to contrast media, L-605 Cobalt-Chromium (Co-Cr) alloy, PLA and PLGA polymers, shellac, Vitamin E-TPGS, paclitaxel, or sirolimus. 6. Patients with a target lesion located within a saphenous vein graft (SVG) or an arterial graft. 7. Patients with target vessels/lesions that are excessively tortuous, angulated, or severely calcified, such that pre-dilatation cannot be performed or has failed, making the application of the investigational medical device difficult.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

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