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Prospective, Multi-center, Single-arm Study of the Auryon Laser System for Treatment of Below-the-Knee (BTK) Arteries

NCT05284240 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-11-21

No results posted yet for this study

Summary

The Auryon Laser Atherectomy System has been cleared by the FDA to treat infrainguinal arterial disease including in-stent restenosis

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

Auryon Laser System

The Auryon BTK Study is a prospective, single arm multicenter study evaluating the safety and procedural effectiveness of the Auryon laser in treating infrapopliteal disease in patients with critical limb ischemia and claudication. The primary exposure of interest for this study is the use of the AURYON system for atherectomy.

Sponsors & Collaborators

  • Angiodynamics, Inc.

    collaborator INDUSTRY

  • Midwest Cardiovascular Research Foundation

    lead OTHER

Principal Investigators

  • Nicolas Shammas · Midwest Cardiovascular Research Foundation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-17
Primary Completion
2024-09-25
Completion
2024-09-25
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 NCT05284240 on ClinicalTrials.gov