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

NCT ID NCT07650578

Not yet recruiting Disease control Sponsor: University of Mons Source: ClinicalTrials.gov ↗

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.

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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)

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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