New rotating catheter aims to unclog leg arteries without major surgery

NCT ID NCT07016698

Recruiting now Disease control Sponsor: C. R. Bard Source: ClinicalTrials.gov ↗

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

Summary

This study is tracking 600 people with peripheral artery disease (PAD) who are treated with the Rotarex device, a rotating catheter that cuts and removes plaque from blocked leg arteries. The goal is to see how well the device restores blood flow and how often serious complications occur within 30 days. Participants must have blockages in the leg arteries suitable for the device and be at least 22 years old.

What this could mean

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

Active substance: Rotarex rotational excisional atherectomy system (a device that cuts and removes plaque from leg arteries)
What this could lead to: If successful, this registry could confirm that the Rotarex device is a safe and effective option for restoring blood flow in leg arteries, helping people with peripheral artery disease avoid more invasive surgery.
What could go wrong: This is an observational registry, not a controlled trial, so it cannot prove the device is better than other treatments. Results may not apply to all patients, and risks include artery damage, bleeding, or the need for repeat procedures.

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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 ARTERIAL DISEASE (PAD)

Contacts and locations

Locations

Radiology and Imaging Specialists
RECRUITING

Lakeland, Florida, 33805, United States
Vital Heart and Vein
RECRUITING

Humble, Texas, 77338, United States

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