Sound wave balloon aims to clear leg arteries without surgery

NCT ID NCT07575568

Not yet recruiting Disease control Sponsor: Cagent Vascular LLC Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early study tests a new device that combines a balloon with sound waves to treat blocked arteries in the legs, a condition called peripheral artery disease (PAD). The device is designed to crack hard plaque and widen the artery. The study will include 30 people with moderate to severe PAD to see if the procedure is safe and works well.

What this could mean

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

Active substance: Serranator Sonic Intravascular Lithotripsy (IVL) System
What this could lead to: If successful, this device could offer a new way to open blocked leg arteries without major surgery, potentially improving blood flow and reducing symptoms like leg pain.
What could go wrong: This is a very early, small study (30 people) testing safety and effectiveness for the first time. The device may not work as hoped, and risks include artery damage, blood clots, or the need for further procedures.

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.

peripheral arterial disease

As listed by the trial registrant

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

PERIPHERAL ARTERY DISEASE

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Other studies related to the condition(s) this trial covers.