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Scoring balloon aims to crack tough heart plaques for better stent fit

NCT ID NCT07650578

Disease control Sponsor: University of Mons 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This trial tests whether a specialized scoring balloon, called Naviscore, can better prepare calcified coronary arteries before placing a drug-eluting stent. Hardened plaques often prevent stents from expanding fully, raising risks of re-narrowing or clots. About 200 adults with moderate to severe calcium buildup in their heart arteries will be randomly assigned to receive either the Naviscore balloon or a standard non-compliant balloon. The main goal is to see if the Naviscore leads to a larger final stent area, measured by ultrasound, at the site of the heaviest calcium.

What this could mean

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

Active substance
Naviscore scoring balloon catheter
What this could lead to
If successful, this device could improve stent placement in patients with hardened arteries, reducing the risk of re-narrowing or clots.
What could go wrong
This is a mid-stage trial with 200 participants, so results may not apply to all patients. The device may not outperform standard balloons, and risks include vessel injury or no benefit.

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 200 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

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: * Patient written consent is given, ≥18 years. * A de novo lesion to be treated in a vessel between 2.5 and 4.0 mm. * Moderate to heavily calcified lesions detected by coronary angiography on two orthogonal views, and confirmed by IVUS if the lesion can be crossed with the catheter. Exclusion Criteria: * Patient \<18 years old. * Pregnant female. * Contraindication to dual antiplatelet therapy. * Thrombocytopenia (under 100 000). * Major surgical intervention planned within one year. * Significant left main lesion. * Chronic total occlusion. * Lesion in a graft. * In-stent restenosis lesion. * Lesion responsible of a ST elevated Myocardial Infarction (STEMI)

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Conditions

The condition(s) this trial relates to.

coronary artery disorder coronary atherosclerosis

As listed by the trial registrant

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

Calcific coronary arteriosclerosis Coronary arterial disease (CAD)

How to take part

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

  1. The places running it

    14 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

  • CHR de la Citadelle

    Liège, 4000, Belgium

  • CHU - HELORA site Kennedy

    Mons, Hainaut, 7000, Belgium

  • Centro Hospitalar de Vila Nova de Gaia/Espinho

    Vila Nova de Gaia, 4430-999, Portugal

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47003, Spain

  • Hospital La Fe

    Valencia, 46026, Spain

  • Hospital Puerta Del Mar

    Cadiz, 11009, Spain

  • Hospital San Pedro de Alcantara

    Cáceres, 10003, Spain

  • Hospital Universitari de Bellvitge

    Barcelona, 08901-08908, Spain

  • Hospital de Sant Pau

    Barcelona, 08025, Spain

  • Humani CHU Charleroi - Chimay

    Lodelinsart, 6042, Belgium

  • Hôpital Erasme - Cliniques universitaires de Bruxelles

    Brussels, 1070, Belgium

  • Hôpital Vivalia

    Libramont, 6800, Belgium

  • INCCI Haerz Zenter

    Luxembourg, 1210, Luxembourg

  • Imelda

    Bonheiden, 2820, Belgium

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