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Heart plaque 'Fingerprinting' could guide better angioplasty

NCT ID NCT07390994

Knowledge-focused Sponsor: Fondazione Ricerca e Innovazione Cardiovascolare ETS 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will use a special camera (OCT) to look inside heart arteries before a standard balloon procedure. Researchers want to see if the type of plaque (fatty, hard, or scar-like) affects how well patients do afterward. About 600 people with coronary artery disease will take part. The goal is to learn, not to test a new drug or device.

What this could mean

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

Active substance
Drug-coated balloon angioplasty
What this could lead to
If successful, this could help doctors choose the best treatment for each patient based on plaque type, potentially improving outcomes.
What could go wrong
This is an observational study, not testing a new treatment. It may not lead to direct changes in care, and results might not apply to all patients.

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 600 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Apr 2027

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

Adult patients with chronic coronary syndrome or acute coronary syndrome who underwent drug-coated balloon angioplasty for de novo obstructive coronary artery disease with preprocedural optical coherence tomography assessment of the target segment.

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: * Chronic coronary syndrome or acute coronary syndrome diagnosis (per ESC guidelines). * De novo obstructive CAD: ≥50% left main stenosis, or any stenosis ≥70%, or FFR \<0.80 in any other major epicardial vessel, or MLA deemed ischemic at intravascular imaging. * OCT assessment of the target segment phenotype prior to lesion preparation and DCB angioplasty. * Successful DCB angioplasty according to DCB ARC criteria. * Patients who underwent DCB-only PCI, or hybrid DCB-DES PCI with at least 20 mm of the target segment treated with DCB. Exclusion Criteria: * Previous revascularization of the target segment with stent. * Hybrid DCB-DES PCI with DCB-treated segment \<20 mm and/or lacking complete OCT assessment of the DCB-treated segment and/or bailout stenting. * Lack of at least 6 months of clinical follow up. * PCI of chronic total occlusion.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

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

Coronary artery disease

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

    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.

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