RecruitingPhase 4NCT06777901

Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone

Randomized Controlled Trial of the Auryon Atherectomy System Used in Combination With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone Treating Infrapopliteal Lesions in Subjects With Critical Limb Ischemia


Sponsor

Angiodynamics, Inc.

Enrollment

224 participants

Start Date

Apr 21, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if the Auryon Atherectomy System with balloon angioplasty safe and effective in treating lower limb blockages. The main question it aims to answer is: Is treatment with Auryon Atherectomy System more effective than angioplasty alone in preventing death, amputation, revascularization and improving patency? Researchers will compare the Auryon Atherectomy System with balloon angioplasty to balloon angioplasty alone.


Eligibility

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Auryon Atherectomy System and a medical device called Balloon Angioplasty for people with peripheral arterial diseases. The study is currently recruiting participants at 9 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAuryon Atherectomy System

Auryon Atherectomy System is composed of a laser and catheter

DEVICEBalloon Angioplasty

Balloon Angioplasty alone


Locations(9)

Abrazo Arizona Heart Hospital

Phoenix, Arizona, United States

Kaiser Permanente

San Diego, California, United States

CIS Grey ASC

Gray, Louisiana, United States

MedStar Health Research Institute

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

The Washington University

St Louis, Missouri, United States

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Prisma Heath-University Medical Group

Greenville, South Carolina, United States

View Full Details on ClinicalTrials.gov

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NCT06777901


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