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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-04

Study Completion Date

2023-04-17

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infrainguinal Peripheral Artery Disease Peripheral Arterial Disease PAD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study patients

Eligible PAD patients who are routinely treated with atherectomy by AURYON™ Atherectomy System.

AURYON™ System

Intervention Type DEVICE

The AURYON™ System consists of two sub-units: 1) a single use catheter ("AURYON™ catheter"); and 2) a laser system.

Interventions

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AURYON™ System

The AURYON™ System consists of two sub-units: 1) a single use catheter ("AURYON™ catheter"); and 2) a laser system.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No