Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease

Completed

Conditions studied: Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease, PAD

In brief

The PATHFINDER Registry is a prospective, non-randomized, single arm, multicenter observational study. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term) of the AURYON Atherectomy System, within the initial launch phase of the product in the market.

Key facts

Study ID

NCT04229563

Run by

Angiodynamics, Inc.

People needed

102

Starts

2020-08-04

Expected to finish

2023-04-17

Last updated by the study team

2026-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is ≥ 18 years old.
• Subject is a candidate for atherectomy for infra-inguinal peripheral artery disease.
• Documented symptomatic atherosclerotic peripheral artery disease with claudication or critical limb ischemia (CLI) (Rutherford Classification 2-5 ).
• Subject is capable and willing to comply with the scheduled follow up
• Subject is able and willing to sign a written Informed Consent Form (ICF).

You may not qualify if…

• Target lesion is in an arterial bypass.
• Planned use of another atherectomy device in the same procedure
• 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.
• Participating in another study on an interventional non-cleared device, that could impact the study results

Where it is running

• Pulse Cardiovacular — Scottsdale, Arizona, United States
• Pima Vascular — Tucson, Arizona, United States
• Comprehensive Cardiovascular — Davenport, Florida, United States
• First Coast Cardiovascular Institute — Jacksonville, Florida, United States
• Amavita Clinical Research — Miami, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Midwest Cardio. research foundation — Davenport, Iowa, United States
• NJ Endovascular Amputation Prevention — Clifton, New Jersey, United States
• Medical City Heart and Spine — Dallas, Texas, United States
• Hurricane Cardiology — New Braunfels, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.