MedTrace Logo

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

NCT06777901 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2026-01-08

No results posted yet for this study

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.

Conditions

  • Peripheral Arterial Diseases

Interventions

DEVICE

Auryon Atherectomy System

Auryon Atherectomy System is composed of a laser and catheter

DEVICE

Balloon Angioplasty

Balloon Angioplasty alone

Sponsors & Collaborators

  • Angiodynamics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-21
Primary Completion
2029-02-28
Completion
2029-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06777901 on ClinicalTrials.gov