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New 3D stent scanner could make heart procedures safer and faster

NCT ID NCT06898021

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a new imaging tool called 3DStent that creates a 3D picture of stents placed in heart arteries. The goal is to see if it can detect when a stent is not fully expanded, which can cause problems. About 200 patients getting a stent will have both the 3DStent scan and a standard ultrasound to compare results.

What this could mean

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

Active substance
3DStent (diagnostic imaging software)
What this could lead to
If successful, 3DStent could provide a simpler, faster way to check stent expansion during heart procedures, potentially reducing the need for invasive ultrasound.
What could go wrong
This is an early observational study with only 200 participants. The technology may not match the accuracy of current imaging methods, and results may 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 200 people

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

Started

Apr 2025

Expected to finish

Dec 2027

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.

Who is studied

Patients presenting with chronic or acute coronary syndromes (ACS) and a clinical indication for PCI

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: * Patient presenting with chronic or acute coronary syndromes (ACS) with a clinical indication for PCI guided by IVUS. Exclusion Criteria: 1. Age \<18 years 2. Coronary lesions requiring total stent length \> 48 mm. 3. Body mass index \>35 kg/m2 4. Uncontrolled recurrent ventricular tachycardia 5. Cardiogenic shock 6. Unable to provide written informed consent (IC).

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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 Percutaneous coronary intervention (PCI)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites in 4 countries. 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

  • AZORG Ziekenhuis

    RECRUITING

    Aalst, Belgium

  • Hospital Clinic

    NOT_YET_RECRUITING

    Barcelona, Spain

  • I.R.C.C.S. Ospedale Galeazzi-Sant'Ambrogio

    NOT_YET_RECRUITING

    Milan, Italy

  • ICPS

    NOT_YET_RECRUITING

    Paris, France

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