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Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone | Clinical Trials | Clareo Health

RECRUITINGPHASE4

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

Randomized Controlled Trial of the Auryon Atherectomy System Used in Combination With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone Treating Infrapopliteal Lesions in Subjects With Critical Limb Ischemia

NCT06777901•Angiodynamics, Inc.

View on ClinicalTrials.gov

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.

Detailed Description

Up to 1500 subjects who do not meet the inclusion/exclusion criteria for the randomized study may satisfy the eligibility criteria for, and be enrolled in, the observational study.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

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.
•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).
+7 more criteria

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.
+14 more criteria

Locations (9)

Abrazo Arizona Heart Hospital

Phoenix, Arizona, United States

Kaiser Permanente

San Diego, California, United States

CIS Grey ASC

Gray, Louisiana, United States

MedStar Health Research Institute

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

The Washington University

St Louis, Missouri, United States

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Prisma Heath-University Medical Group

Greenville, South Carolina, United States

Key Dates

Start Date

April 21, 2025

Primary Completion Date

February 1, 2029

Completion Date

April 1, 2029

Last Updated

January 8, 2026

Enrollment

224

ESTIMATED participants

Conditions

Peripheral Arterial Diseases

Interventions

Auryon Atherectomy System

DEVICE

Balloon Angioplasty

DEVICE

Contacts

Anna Quillin

CONTACT

2196281806 anna.quillin@angiodynamics.com

Liz Manning

CONTACT

liz.manning@angiodynamics.com

Intervascular Post-Market Clinical Follow-Up (PMCF) Registry

NCT07322913

Carotid Artery DiseasesAortic Diseases+1 more

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RECRUITING

Transcutaneous Oxygen Pressure (TcPO2) Determination.

NCT05192707

Peripheral Arterial Diseases

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COMPLETEDPHASE4

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 8, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Intervascular Post-Market Clinical Follow-Up (PMCF) Registry

Transcutaneous Oxygen Pressure (TcPO2) Determination.

The Jetstream (JET) Post-market Registry