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Balloon blasts fat in arteries: could it prevent heart attacks?

NCT ID NCT07107971

Disease control Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a drug-coated balloon can reduce fatty deposits in heart arteries better than standard medications alone. Researchers will enroll 400 adults who recently had a heart-related event (acute coronary syndrome). Participants will get either the balloon treatment plus medication or medication only, and doctors will use imaging to track plaque changes over 9 months.

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
What this could lead to
If it works, this could offer a new way to stabilize dangerous heart plaques and reduce the risk of future heart attacks.
What could go wrong
This is an early-stage trial with 400 participants, so results may not apply to everyone. The balloon treatment also carries risks like vessel injury or allergic reaction to the drug.

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 400 people

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

Started

Nov 2025

Expected to finish

Jan 2033

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: * Presenting with acute coronary syndrome (ACS); * Successful PCI of a native coronary artery or major side branch; * At least 2 native coronary arteries are accessible for invasive coronary imaging; i.e. not totally occluded and \>2 mm and \<6 mm reference vessel diameter. Exclusion Criteria: * Hemodynamically unstable (presence of cardiogenic shock, need for intubation, need for inotropes); * Known hypersensitivity to paclitaxel; * Procedural complications of the index PCI; * Known renal insufficiency, i.e. eGFR \<30 mL/min/1.73 m2; * Hypersensitivity or allergy to contrast with inability to administer steroid and antihistamine premedication; * Presence of a comorbid condition with a life expectancy of less than one year; * Body weight \>250 kg; * Subject belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff) or is unable to read or write.

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome atherosclerosis cardiovascular disorder coronary artery disorder coronary atherosclerosis

As listed by the trial registrant

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

Acute coronary syndromes (ACS) Atheroscleroses Cardiovascular disease Coronary artery disease Lipid-rich atherosclerosis of coronary artery Vulnerable coronary plaques Vulnerable plaque

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

  • Amsterdam UMC

    RECRUITING

    Amsterdam, Netherlands

More trials for these conditions

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