← Back to Search

Atherectomy Device

Auryon Laser System for Peripheral Arterial Disease

N/A
Waitlist Available
Led By Nicolas Shammas
Research Sponsored by Midwest Cardiovascular Research Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Target lesions(s) must be viewed angiographically and have ≥50% stenosis
Target lesion is denovo or restenotic
Must not have
Patient unable to take anticoagulant or antiplatelet agents
Subject has a CVA or TIA within 4 weeks prior to the Auryon procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 months
Awards & highlights
No Placebo-Only Group

Summary

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

Who is the study for?
This trial is for adults over 18 with critical limb ischemia in the leg, specifically from the knee to the ankle. Participants must have a blocked artery that's at least 50% narrowed and agree to follow-up evaluations. People can't join if they've had recent strokes or bleeding issues, are on dialysis, pregnant, or enrolled in another study that conflicts.
What is being tested?
The Auryon Laser System is being tested for its effectiveness in treating below-the-knee arteries affected by Peripheral Vascular Disease and Peripheral Arterial Disease. The system has FDA clearance for infrainguinal arterial disease including in-stent restenosis.
What are the potential side effects?
Potential side effects of using the Auryon Laser System may include discomfort at the treatment site, bruising or bleeding, risk of infection, and possible damage to surrounding tissues or vessels during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My target lesion is more than half blocked as seen in an angiogram.
Select...
My target lesion is new or has previously been treated and narrowed again.
Select...
Only one of my blood vessels is being studied.
Select...
I am 18 years old or older.
Select...
My leg has severe blockage and pain from the knee to the ankle.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot take blood thinners or medications that prevent blood clots.
Select...
I had a stroke or mini-stroke less than 4 weeks before the Auryon procedure.
Select...
I might have an infection affecting my whole body.
Select...
My platelet count is below 80,000 or I have a bleeding disorder.
Select...
I have not had COVID-19 in the last 30 days.
Select...
My procedure to cross the lesion with a guidewire was unsuccessful.
Select...
I have not had brain or stomach bleeding in the last 3 months.
Select...
I am scheduled for a major leg amputation.
Select...
I have untreated significant leg artery blockages below the knee.
Select...
I understand the study and follow medical advice.
Select...
My target lesion is in a graft.
Select...
I am on dialysis.
Select...
I have a sudden loss of blood flow to my limb.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The Primary Performance Endpoint
The Primary Safety Endpoint
Secondary study objectives
Ankle-brachial Index (ABI) or Toe-brachial Index (TBI)
Clinically Relevant Target Lesion Revascularization
EQ-5D-5L Questionnaire
+11 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Auryon Laser Treatment ArmExperimental Treatment1 Intervention
Auryon Laser to be used on target lesion in the below the knee artery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Auryon Laser System
2022
N/A
~60

Find a Location

Who is running the clinical trial?

Midwest Cardiovascular Research FoundationLead Sponsor
5 Previous Clinical Trials
264 Total Patients Enrolled
3 Trials studying Peripheral Arterial Disease
176 Patients Enrolled for Peripheral Arterial Disease
Angiodynamics, Inc.Industry Sponsor
25 Previous Clinical Trials
2,793 Total Patients Enrolled
1 Trials studying Peripheral Arterial Disease
104 Patients Enrolled for Peripheral Arterial Disease
Nicolas ShammasPrincipal InvestigatorMidwest Cardiovascular Research Foundation

Media Library

Auryon Laser System (Atherectomy Device) Clinical Trial Eligibility Overview. Trial Name: NCT05284240 — N/A
Peripheral Arterial Disease Research Study Groups: Auryon Laser Treatment Arm
Peripheral Arterial Disease Clinical Trial 2023: Auryon Laser System Highlights & Side Effects. Trial Name: NCT05284240 — N/A
Auryon Laser System (Atherectomy Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05284240 — N/A
~16 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top