Recruiting

Phase 4

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

Sponsor:

Angiodynamics, Inc.

Code:

NCT06777901

Conditions

Peripheral Arterial Diseases

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Auryon Atherectomy System

Balloon Angioplasty

Study Details

Brief 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

Study ID

NCT06777901

Start date

Apr 21, 2025

Status verified date

May, 2025

Completion date

Apr, 2029

Anticipated

Primary completion date

Feb, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Age of subject is ≥ 18.
Estimated life expectancy ≥1 year.
Subject is able and willing to comply with all assessments in the study.
Subject has been informed of the nature of the study, agrees to participate, and has signed the approved consent form.
Rutherford Category classification of 4 or 5 of the target limb.
Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guidelines.

Angiographic Inclusion Criteria

Target lesion that is located in a native, de novo infra-popliteal artery (extending from P3 of the popliteal artery to the margin of the ankle mortise).
Target lesions(s) must be viewed angiographically and have 50-100% stenosis.
Only a single lesion is included in the study per subject.
The vessel segment distal to the target lesion must be patent all the way to the ankle, with no significant lesion (≥ 50% stenosis).
Lesion length ≥50mm and ≤300mm.
Intraluminal crossing of the lesion. Successful crossing is defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations. If this is not certain, IVUS or OCT may be used to verify this at the operator's discretion.
Target Lesion reference vessel diameter (RVD) between 1.5mm - 4.5mm by investigator estimate.

Exclusion Criteria:

Target lesion is in a vessel graft or synthetic graft.
Treatment of target lesion with radial access.
Planned target limb major amputation (above-the-ankle).
Acute limb ischemia or required thrombolysis as a primary treatment modality of the target limb.
History of prior endovascular or surgical procedure on the index limb within 30 days prior to enrollment or planned within 30 days of the index procedure.
Subject is pregnant or breastfeeding. (Female subjects of childbearing potential must be non-breastfeeding and have a negative pregnancy test ≤ 7 days before the procedure.)
Subject has a known coagulopathy or has bleeding diatheses/disorder, thrombocytopenia with platelet count less than 100,000/microliter / less than 80,000K.
Subject in whom antiplatelet or anticoagulant therapy is contraindicated.
Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
Myocardial infarction within 60 days prior to enrollment.
History of stroke/CVA/TIA within 60 days prior to enrollment.
History of thrombolytic therapy within 14 days of enrollment.
Subject has acute or chronic renal disease defined as serum creatinine of >2.5 mg/dL or >220 umol/L, or is on dialysis.
Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the study requirements and evaluations pre- and post-treatment.
Subject experiencing ongoing cardiac problems that per the investigator judgment would not make the subject ideal per the procedure.
Subject has evidence of intracranial or gastrointestinal bleeding within the past 3 months.

Angiographic Exclusion Criteria

Failure to treat clinically significant inflow lesions in the ipsilateral iliac, femoral, or P1-P2 segments of the popliteal arteries with <50% residual stenosis with no serious angiographic complications (e.g., embolism or dissection) prior to treatment of the target lesion.
Residual stenosis, and/or serious angiographic complications (e.g., embolism) prior to the investigational device usage.
The use of adjunctive devices to treat the target lesion other than the investigative Auryon laser catheter and/or PTA devices, such as scoring balloons, drug-eluting balloons, re-entry devices, lithotripsy devices, or other atherectomy devices (with the exception of bailout stents for Class C/D dissections).

Subjects that do not meet eligibility criteria for the randomized controlled trial are eligible to be enrolled in the observational study.

Observational Study Inclusion Criteria:

Subjects intended to be treated with the Auryon Atherectomy System for de-novo, restenotic or ISR lesions of the infra-popliteal arteries.
Subjects presenting with symptomatic PAD with claudication or CLI by Rutherford Category 2 - 6 of the target limb.
Age of subject is ≥ 18.
Subject has been informed of the nature of the study, agrees to participate, and has signed the approved study consent form.

Observational Study Exclusion Criteria:

Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Auryon Atherectomy System as per Instructions for Use (IFU) or investigator's opinion.
Subject is pregnant or breastfeeding. (Female subjects of childbearing potential must be non-breastfeeding and have a negative pregnancy test ≤ 7 days before the procedure.)
Subject is already enrolled in other investigational (interventional) studies that would interfere with study endpoints.

Study Design

Enrollment

224 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Auryon Atherectomy System and Balloon Angioplasty

Subjects will be treated with the Auryon Atherectomy System followed by Percutaneous Balloon Angioplasty

active comparator: Balloon Angioplasty Only

Subjects assigned to this treatment group will be treated with percutaneous balloon angioplasty only.

Interventions

Auryon Atherectomy System

Auryon Atherectomy System is composed of a laser and catheter

Balloon Angioplasty

Balloon Angioplasty alone

Primary outcome measure

Win-ratio comparing subjects in the treatment group versus the control group on the components of the composite endpoints in a hierarchical fashion at 12 months [ Time Frame: From enrollment to the end of treatment at 12 months ]

Central Contacts and Locations

Central contacts

Anna Quillin

2196281806 anna.quillin@angiodynamics.com

Liz Manning

liz.manning@angiodynamics.com

Locations

Abrazo Arizona Heart Hospital

Recruiting

Phoenix, Arizona, United States, 85204

Contacts

Ryleigh Alfonso

480-433-7311 ryleigh.alfonso@axsendoclinical.com

Principal Investigator:

Stephen Smith, MD

Kaiser Permanente

Recruiting

San Diego, California, United States, 92123

Contacts

Michael Fechter

858-266-6604 michael.d.fechter@kp.org

Principal Investigator:

Michael Girard, MD

CIS Grey ASC

Recruiting

Gray, Louisiana, United States, 70359

Contacts

Deanna Benoit

(985) 873-5613 deanna.benoit@cardio.com

Principal Investigator:

Craig Walker, M.D

MedStar Health Research Institute

Recruiting

Baltimore, Maryland, United States, 21218

Contacts

Keith Moyer

443-278-9170 keith.t.moyer@medstar.net

Principal Investigator:

Jason Crowner, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Jaimie Atwood

617-726-2264 jlattwood@mgh.harvard.edu

Principal Investigator:

Anahita Dua, MD

The Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Isabella Mineiro

mineiro@wustl.edu

Principal Investigator:

Carlos Guevara, MD

University of North Carolina Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Amber Daino

amber_fix@med.unc.edu

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Christopher Ernst

216-844-7637 christopher.ernst@uhhospitals.org

Principal Investigator:

Jun Li, MD

Prisma Heath-University Medical Group

Recruiting

Greenville, South Carolina, United States, 29601

Contacts

Maggie Salle

864-607-3405 margaret.salle@prismahealth.org

Principal Investigator:

Sagar Gandhi, MD

More Information

Sponsor

Angiodynamics, Inc.

Last update posted

Jan 8, 2026

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Angiodynamics, Inc. on 2026-01-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.