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RECRUITING
NCT06777901
PHASE4

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

Sponsor: Angiodynamics, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

224

Start Date

2025-04-21

Completion Date

2029-04

Last Updated

2026-01-08

Healthy Volunteers

No

Interventions

DEVICE

Auryon Atherectomy System

Auryon Atherectomy System is composed of a laser and catheter

DEVICE

Balloon 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