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Post-Market Registry of AURYON™ Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease | Clinical Trials | Clareo Health

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

PATHFINDER I: Post-Market Registry of AURYON™ Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease (PATHFINDER-Registry, EX-PAD-05)

NCT04229563•Angiodynamics, Inc.

View on ClinicalTrials.gov

Summary

The PATHFINDER I Registry is a prospective, non-randomized, single arm, multicenter observational study. It is a pilot registry study towards a subsequent large pivotal phase registry. 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.

Detailed Description

US multicenter, prospective, single-arm, observational post market Registry. A pilot registry towards a subsequent large pivotal registry (PATHFINDER II), aimed to evaluate the safety and efficacy of Auryon™ Atherectomy System in the treatment of de novo, re-stenotic and ISR lesions in infra-inguinal arteries of Peripheral Artery Diseases (PAD) subjects, in a real-world setting within the initial launch phase of the product in the market.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (5)

Pulse Cardiovacular

Scottsdale, Arizona, United States

Pima Vascular

Tucson, Arizona, United States

Comprehensive Cardiovascular

Davenport, Florida, United States

Midwest Cardio. research foundation

Davenport, Iowa, United States

Hurricane Cardiology

New Braunfels, Texas, United States

Key Dates

Start Date

August 4, 2020

Primary Completion Date

March 17, 2021

Completion Date

April 17, 2023

Last Updated

February 21, 2023

Enrollment

104

ACTUAL participants

Conditions

Infrainguinal Peripheral Artery DiseasePeripheral Arterial DiseasePAD

Interventions

AURYON™ System

DEVICE

Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

NCT07472049

Peripheral Arterial DiseaseChronic Limb Threatening Ischemia

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RECRUITING

Advanta VXT and Flixene PMCF Registry

NCT07161583

Peripheral Arterial Disease

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RECRUITING

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: February 21, 2023Data 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.

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

Inclusion Criteria

Exclusion Criteria

Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

Advanta VXT and Flixene PMCF Registry

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

VITUS Post-Market Registry

The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial)

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