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Balloon treatment aims to defuse 'Time Bomb' plaques in heart arteries

NCT ID NCT04765956

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether a drug-coated balloon can stabilize fatty plaques in heart arteries that are at risk of rupturing and causing a heart attack. Researchers treated 45 patients with a recent heart condition, using a special balloon to deliver medication directly to the plaque. The goal was to see if the plaque becomes less dangerous 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
drug-eluting balloon (a balloon coated with an antiproliferative drug)
What this could lead to
If it works, this could point toward a way to treat vulnerable plaques before they cause a heart attack, potentially reducing future cardiac events.
What could go wrong
This is a small, early-phase trial with only 45 participants and no control group, so results may not apply broadly. The treatment itself carries risks like artery dissection or need for emergency stenting.

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

45 people

The number who actually took part.

Started

Jan 2021

Finished

Sep 2023

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Patient has an acute coronary syndrome without ST-segment elevation on the ECG (NSTE-ACS), including non-ST-elevation myocardial infarction and unstable angina pectoris, defined according to the Fourth Universal Definition of Myocardial Infarction. * An invasive revascularization strategy for NSTE-ACS with PCI is chosen. Exclusion Criteria: \- Angiographic exclusion criteria: 1. Previous coronary artery bypass-grafting; 2. Presence of a chronic total occlusion; 3. Too many (complex) coronary lesions requiring staged PCI procedure(s); 4. Procedural complication of the index PCI; \- Clinical exclusion criteria: 5. Unstable patients (the presence of cardiogenic shock, need for intubation, need for inotropes); 6. Patients with ST-segment elevations on the ECG requiring immediate primary PCI; 7. Body weight \> 250 kg; 8. Known renal insufficiency (estimated Glomerular Filtration Rate \[eGFR\] \<30 mL/min/1.73m2 or subject on dialysis); 9. Hypersensitivity or allergy to contrast with inability to properly pre-hydrate; 10. Presence of a comorbid condition with a life expectancy of less than one year; 11. Participation in another trial; 12. Subject is 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 coronary artery disorder Non-ST Elevated Myocardial Infarction

As listed by the trial registrant

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

Coronary artery disease

Contacts and locations

Locations

  • Amsterdam UMC, location AMC

    Amsterdam, 1105AZ, Netherlands

More trials for these conditions

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