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Laser catheter shows promise for unclogging leg arteries

NCT ID NCT04229563

Disease control Sponsor: Angiodynamics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how well the AURYON atherectomy device works for people with peripheral artery disease (PAD), where leg arteries become blocked. The device uses a laser to vaporize plaque and restore blood flow. Researchers followed 102 patients to see if the procedure was safe and effective right after treatment and over time. The goal was to see if the device could clear blockages with few complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AURYON Atherectomy System (a laser catheter device)
What this could lead to
If successful, this device could offer a safe and effective way to clear blockages in leg arteries, improving blood flow and reducing symptoms like pain or wounds.
What could go wrong
This is a small, single-arm registry (102 people) with no comparison group, so results may not apply to everyone. Risks include vessel damage, blood clots, or need for further procedures.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

102 people

The number who actually took part.

Started

Aug 2020

Finished

Apr 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with infra-inguinal PAD undergoing atherectomy with the AURYON Atherectomy System.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject is ≥ 18 years old. 2. Subject is a candidate for atherectomy for infra-inguinal peripheral artery disease. 3. Documented symptomatic atherosclerotic peripheral artery disease with claudication or critical limb ischemia (CLI) (Rutherford Classification 2-5 ). 4. Subject is capable and willing to comply with the scheduled follow up 5. Subject is able and willing to sign a written Informed Consent Form (ICF). Exclusion Criteria: 1. Target lesion is in an arterial bypass. 2. Planned use of another atherectomy device in the same procedure 3. Co-morbid condition(s) with less than 1yr anticipated survival that could limit the subject's ability to participate in the trial or to comply with follow-up requirements or impact the scientific integrity of the study. 4. Participating in another study on an interventional non-cleared device, that could impact the study results

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Conditions

The condition(s) this trial relates to.

Arterial Occlusive Diseases Bites and Stings Chronic Limb-Threatening Ischemia intermittent vascular claudication peripheral arterial disease peripheral vascular disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Infrainguinal peripheral artery disease PAD Peripheral arterial disease

Contacts and locations

Locations

  • Amavita Clinical Research

    Miami, Florida, 33169, United States

  • Comprehensive Cardiovascular

    Davenport, Florida, 33837, United States

  • First Coast Cardiovascular Institute

    Jacksonville, Florida, 32256, United States

  • Hurricane Cardiology

    New Braunfels, Texas, 78130, United States

  • Medical City Heart and Spine

    Dallas, Texas, 75243, United States

  • Midwest Cardio. research foundation

    Davenport, Iowa, 52803, United States

  • NJ Endovascular Amputation Prevention

    Clifton, New Jersey, 07013, United States

  • Pima Vascular

    Tucson, Arizona, 85718, United States

  • Pulse Cardiovacular

    Scottsdale, Arizona, 85259, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

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