Laser tool aims to save legs from amputation in blockage trial

NCT ID NCT06777901

Recruiting now Disease control Sponsor: Angiodynamics, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a laser device called the Auryon Atherectomy System, used with standard balloon angioplasty, works better than balloon angioplasty alone for people with severe leg artery blockages (critical limb ischemia). The trial will enroll 224 adults who are at risk of amputation. Researchers will compare rates of death, amputation, repeat procedures, and blood flow improvement over 12 months.

What this could mean

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

Active substance: Auryon Atherectomy System (laser device) used with balloon angioplasty
What this could lead to: If it works, this could offer a better way to treat severe leg blockages, reducing the need for amputation or repeat procedures.
What could go wrong: This is a phase 4 trial, but the device may not prove more effective than balloon angioplasty alone. There are risks like vessel damage or incomplete clearing of blockages.

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.

limb ischemia peripheral arterial disease

As listed by the trial registrant

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

PERIPHERAL ARTERIAL DISEASES

Contacts and locations

Locations

Abrazo Arizona Heart Hospital
RECRUITING

Phoenix, Arizona, 85204, United States
CIS Grey ASC
RECRUITING

Gray, Louisiana, 70359, United States
Kaiser Permanente
RECRUITING

San Diego, California, 92123, United States
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02114, United States
MedStar Health Research Institute
RECRUITING

Baltimore, Maryland, 21218, United States
Prisma Heath-University Medical Group
RECRUITING

Greenville, South Carolina, 29601, United States
The Washington University
RECRUITING

St Louis, Missouri, 63110, United States
University Hospitals Cleveland Medical Center
RECRUITING

Cleveland, Ohio, 44106, United States
University of North Carolina Chapel Hill
RECRUITING

Chapel Hill, North Carolina, 27599, United States

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