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NCT Number: NCT04229563

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

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.

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Key information

Conditions

Infrainguinal Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Bites and Stings Cardiovascular Diseases Chemically-Induced Disorders Chronic Disease Chronic Limb-Threatening Ischemia Disease Attributes Intermittent Claudication Ischemia PAD Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Poisoning Signs and Symptoms Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pulse Cardiovacular, Scottsdale, Arizona, United States

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About this study

US multicenter, prospective, single-arm, observational post market Registry. A pilot registry 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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

Treatment and study plan

Auryon Atherectomy System

Device

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

Primary outcomes

  1. Primary Efficacy: Acute Procedural Success

    Time frame: Peri-procedural (by the end of the index procedure)

    Percentage of lesions with successful revascularization of target vessel defined as ≤30% residual stenosis at the treated lesion post Auryon atherectomy and final adjunctive treatment (if required), as evaluated by angiographic corelab.

  2. Primary Safety: Freedom From Peri-procedural Major Adverse Events (PPMAE)

    Time frame: Through discharge, an average of 5 days

    Percentage of subjects with freedom from peri-procedural major adverse events (PPMAE), defined as (a) flow-limiting dissection, (b) clinically significant distal embolization, (c) bailout stenting, (d) major/unplanned amputation, (e) target vessel perforation requiring endovascular or surgical repair or (f) death, till discharge.

Secondary outcomes

  1. Number of Participants With Device Related Complications Requiring Intervention

    Time frame: Till discharge, an average of 5 days

    Number of participants with device related complications requiring intervention, defined as peri procedural Major Adverse Events (MAEs), reported by the operating physician as caused directly due to the use of the AURYON device.

  2. Number of Participants With Major Adverse Events (MAEs) Over Time

    Time frame: Post-discharge (at 30-days, 6-, 12-, and 24-months)

    Number of participants with post-discharge MAEs over time; defined as: (a) Unplanned target limb amputation, (b) cardiovascular death, (c) clinically driven target lesion revascularization, (d) target vessel revascularization (TVR).

  3. Number of Patent Lesions

    Time frame: Post-discharge (at 6-, 12-, and 24-months)

    Number of patent lesions, defined as <50% stenosis at the treated lesion, with peak systolic velocity ratio (PSVR) of <2.5, as assessed quantitatively by Duplex ultrasonography (DUS), at 6, 12, and 24 months.

  4. Freedom From Occlusion

    Time frame: Post-discharge (at 6-, 12-, and 24-months)

    Number of below-the-knee (BTK) lesions with freedom from occlusion (100% stenosis by DUS) combined with freedom from clinically-driven target lesion revascularization (CD-TLR)

  5. Change From Baseline in Ankle Brachial Index (ABI)/Tibial Brachial Index (TBI)

    Time frame: Post-discharge (at 6-, 12-, and 24-months)

    Change in ankle brachial index (ABI) or tibial brachial index (TBI) if ABI unavailable at 6, 12, and 24, months, compared to baseline.

    Ankle-Brachial Index (ABI) is an ankle/arm blood pressure ratio. Normal value ranges between 0.9-1.3. Under 0.9 index means blood has a difficult time getting to legs and feet; 0.4-0.9 indicates mild-moderate peripheral artery disease (PAD); 0.4 and lower indicates severe PAD. Positive change between timepoints represents a clinical improvement over time.

  6. Change From Baseline in Walking Impairment Questionnaire (WIQ)

    Time frame: Post-discharge (at 6-, 12-, and 24-months)

    Change in walking impairment questionnaire (WIQ) score at 6, 12, and 24, months, compared to baseline.

    WIQ is a patient reported outcome (survey) to grade physical ability representing PAD progress. It has 3 sub-scales (walking speed, distance, climbing stairs), with the total score ranging between 0-100. A higher score means less impairment; positive change between timepoints represents a clinical improvement through time.

  7. Change From Baseline in Rutherford Clinical Category (RCC)

    Time frame: Post-discharge (at 6-, 12-, and 24-months)

    Change in Rutherford Clinical Category at 6, 12, and 24, months, compared to baseline.

    Rutherford Category is a physician-assessed measurement, with 7 stages (0= Asymptomatic to 6= Severe ischemic ulcers/frank gangrene) representing PAD progress. Lower value means less impairment. Positive difference between timepoints represents a clinical deterioration over time.

Sponsors and collaborators

Lead sponsor

Angiodynamics, Inc.

Industry

Registry information

Official study title

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

Acronym: PATHFINDER

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Jan 18, 2020
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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