Auryon Laser System for Peripheral Arterial Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Peripheral Arterial Disease+1 More
Auryon Laser System - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial found that the Auryon Laser Atherectomy System was effective in treating infrainguinal arterial disease, including in-stent restenosis.

Eligible Conditions
  • Peripheral Arterial Disease

Treatment Effectiveness

Study Objectives

2 Primary · 14 Secondary · Reporting Duration: 6 and 12 months

12 months
Clinically Relevant Target Lesion Revascularization
30 days
Major Adverse Events (MAE)
The Primary Safety Endpoint
Month 12
EQ-5D-5L Questionnaire
Healed Wounds
Rutherford Category
Walking impairment questionnaire
Month 12
Ankle-brachial Index (ABI) or Toe-brachial Index (TBI)
6 and 12 months
Primary patency at 6 and 12 month
Index Procedure
Mean Lesion Diameter
Perforations
Serious angiographic complications
Subgroup analysis stratified by IVUS
Technical success
The Primary Performance Endpoint
Total Dissections

Trial Safety

Trial Design

1 Treatment Group

Auryon Laser Treatment Arm
1 of 1

Experimental Treatment

60 Total Participants · 1 Treatment Group

Primary Treatment: Auryon Laser System · No Placebo Group · N/A

Auryon Laser Treatment Arm
Device
Experimental Group · 1 Intervention: Auryon Laser System · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 and 12 months

Who is running the clinical trial?

Midwest Cardiovascular Research FoundationLead Sponsor
5 Previous Clinical Trials
472 Total Patients Enrolled
3 Trials studying Peripheral Arterial Disease
384 Patients Enrolled for Peripheral Arterial Disease
Angiodynamics, Inc.Industry Sponsor
21 Previous Clinical Trials
2,203 Total Patients Enrolled
1 Trials studying Peripheral Arterial Disease
104 Patients Enrolled for Peripheral Arterial Disease
Nicolas ShammasPrincipal InvestigatorMidwest Cardiovascular Research Foundation

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
If you are 18 or older, you have a lesion that crosses the lumen of the vessel.
A lesion is eligible if its RVD is between 1.5 mm and 4.5 mm
You have a target lesion that is denovo or restenotic.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 16th, 2021

Last Reviewed: November 11th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.