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

NCT ID NCT07650578

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • CHR de la Citadelle

    Liège, 4000, Belgium

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • CHU - HELORA site Kennedy

    Mons, Hainaut, 7000, Belgium

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Centro Hospitalar de Vila Nova de Gaia/Espinho

    Vila Nova de Gaia, 4430-999, Portugal

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47003, Spain

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Hospital La Fe

    Valencia, 46026, Spain

    Contact Email: •••••@•••••

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Hospital Puerta Del Mar

    Cadiz, 11009, Spain

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Hospital San Pedro de Alcantara

    Cáceres, 10003, Spain

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Hospital Universitari de Bellvitge

    Barcelona, 08901-08908, Spain

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Hospital de Sant Pau

    Barcelona, 08025, Spain

    Contact Phone: •••-•••-••••

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Humani CHU Charleroi - Chimay

    Lodelinsart, 6042, Belgium

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Hôpital Erasme - Cliniques universitaires de Bruxelles

    Brussels, 1070, Belgium

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Hôpital Vivalia

    Libramont, 6800, Belgium

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • INCCI Haerz Zenter

    Luxembourg, 1210, Luxembourg

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Imelda

    Bonheiden, 2820, Belgium