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Heart arteries without metal: CT scans track Drug-Coated balloon results

NCT ID NCT07811960

Disease control Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 17, 2026 · Updated 3 times

Summary

Researchers are studying how heart arteries change after a blocked vessel is opened with a paclitaxel drug-coated balloon instead of a metal stent. The balloon delivers a drug to the artery wall and then is removed, leaving no permanent implant. About 150 adults who had this procedure receive CT scans of their heart arteries shortly after treatment and again nine months later. The scans measure blood flow and plaque buildup to see whether the treated artery stays open over time.

What this could mean

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

Active substance
a paclitaxel drug-coated balloon used during angioplasty
What this could lead to
If the scans show the treated artery keeps good blood flow without a metal stent, doctors could rely more on drug-coated balloons and avoid leaving permanent implants in heart arteries.
What could go wrong
This is a small registry study of 150 people with no comparison group, so it can show how arteries change over time but cannot prove the balloon works better than a stent. CT scans also require contrast dye, which some people cannot safely receive.

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.

Participants

About 150 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 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.

Who is studied

Consecutive patients aged 18 years or older scheduled for PCI of a native coronary artery will be screened for inclusion in the trial. Patients will be included at the Amsterdam UMC.

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; * Presence of a de novo lesion; * Successful DCB-PCI of a native coronary artery or major side branch. Exclusion Criteria: * No Protégé DCB was used; * Previous CABG; * Ineligibility for CCTA acquisition due to: * Known renal insufficiency, i.e. eGFR ≤ 30 mL/min/1.73m²; * Known hypersensitivity or contraindication to CT contrast agents; * Body weight \> 150 kg. * Metallic implants in or around the target vessel; * Pregnancy or pregnancy status unknown; * Presence of a comorbid condition with a life expectancy of less than one year; * Inability to provide informed consent

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome coronary artery disorder

As listed by the trial registrant

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

Acute coronary syndromes (ACS) Coronary arterial disease (CAD) Stable coronary artery disease undergoing pci

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  2. A doctor treating you

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