Sound wave device aims to crack hardened heart arteries

NCT ID NCT07510438

Recruiting now Disease control Sponsor: Amplitude Vascular Systems, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This first-in-human study tests a new device called Pulse IVL that uses sound waves to break up calcium buildup in heart arteries. Up to 15 people with coronary artery disease will receive the treatment before getting a stent. The goal is to see if the device is safe and helps open the artery enough for successful stenting.

What this could mean

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

Active substance: Pulse Intravascular Lithotripsy (Pulse IVL) device
What this could lead to: If successful, this device could offer a safer way to prepare hardened arteries for stenting, potentially improving blood flow and reducing complications.
What could go wrong: This is a very early, small study with only 15 people. The device may not work as expected or could cause vessel damage. More research is needed before it becomes widely available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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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 ARTERIAL DISEASE (CAD)

Contacts and locations

Locations

Auckland City Hospital
RECRUITING

Auckland, 1142, New Zealand
Monash Health, Victorian Heart Hospital
RECRUITING

Melbourne, Victoria, 3168, Australia

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