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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My target lesion is more than half blocked as seen in an angiogram.
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My target lesion is new or has previously been treated and narrowed again.
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Only one of my blood vessels is being studied.
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I am 18 years old or older.
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My leg has severe blockage and pain from the knee to the ankle.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The Primary Performance Endpoint
The Primary Safety Endpoint
Secondary outcome measures
Ankle-brachial Index (ABI) or Toe-brachial Index (TBI)
Clinically Relevant Target Lesion Revascularization
EQ-5D-5L Questionnaire
+11 moreTrial 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.
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
23 Previous Clinical Trials
2,305 Total Patients Enrolled
1 Trials studying Peripheral Arterial Disease
104 Patients Enrolled for Peripheral Arterial Disease
Nicolas ShammasPrincipal InvestigatorMidwest Cardiovascular Research Foundation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to contrast dye and cannot be pre-treated for the allergy.I cannot take blood thinners or medications that prevent blood clots.I had a stroke or mini-stroke less than 4 weeks before the Auryon procedure.I might have an infection affecting my whole body.My target lesion is more than half blocked as seen in an angiogram.My platelet count is below 80,000 or I have a bleeding disorder.My leg artery blockages were treated without major issues and less than 30% narrowing remains.I am scheduled to use a special device or balloon along with the Auryon laser treatment.I have not had, nor plan to have, any surgery or endovascular procedures within 14 days of the index procedure.The doctor thinks you might not live for more than a year.I have not had COVID-19 in the last 30 days.My procedure to cross the lesion with a guidewire was unsuccessful.The blood vessel where the targeted lesion is located is estimated to be between 1.5 mm and 4.5 mm in diameter by the doctor.My target lesion is new or has previously been treated and narrowed again.I have not had brain or stomach bleeding in the last 3 months.Only one of my blood vessels is being studied.The study will include participants with certain types of lesions, and the use of IVUS may be decided by the doctor to confirm the type of lesion.I am scheduled for a major leg amputation.I have untreated significant leg artery blockages below the knee.You have a condition called in-stent restenosis.I am 18 years old or older.I understand the study and follow medical advice.My target lesion is in a graft.I am on dialysis.My leg has severe blockage and pain from the knee to the ankle.I have a sudden loss of blood flow to my limb.
Research Study Groups:
This trial has the following groups:- Group 1: Auryon Laser Treatment Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the main aim of this research endeavor?
"Based on the details provided by Angiodynamics, Inc., the primary outcome that will be measured during a pre-defined period is The Primary Safety Endpoint. In addition, this trial aims to evaluate further metrics such as Perforations which necessitate an intervention; Primary patency at 6 and 12 months which is determined via total occlusion (100% diameter stenosis) and CD-TLR; Walking impairment questionnaire scores relative to baseline measurements."
Answered by AI
Is this experiment still enlisting participants?
"Indeed, the information on clinicaltrials.gov implies that this trial is currently open for recruitment. The research project was introduced to the public on March 17th 2022 and has since seen a few modifications up until April 4th 2022. There are 60 open positions between two different medical centers."
Answered by AI
What is the size of the cohort participating in this clinical trial?
"Yes, according to information published on clinicaltrials.gov this research initiative is still recruiting participants. It was first made available for public view on 17th of March 2022 and the most recent update was issued in early April of that same year. The study requires 60 individuals from two medical centres to join its ranks."
Answered by AI
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