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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Peripheral Arterial Disease; PAD; Infrainguinal Peripheral Artery Disease
• Intervention / Treatment: Device: AURYON™ System

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.

• Study Type: Observational
• Enrollment (Actual): 104

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Pulse Cardiovacular
    • Tucson, Arizona, United States, 85718
      • Pima Vascular
  • Florida
    • Davenport, Florida, United States, 33837
      • Comprehensive Cardiovascular
  • Iowa
    • Davenport, Iowa, United States, 52803
      • Midwest Cardio. research foundation
  • Texas
    • New Braunfels, Texas, United States, 78130
      • Hurricane Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study patients; Eligible PAD patients who are routinely treated with atherectomy by AURYON™ Atherectomy System.	Device: AURYON™ System; The AURYON™ System consists of two sub-units: 1) a single use catheter ("AURYON™ catheter"); and 2) a laser system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Efficacy: Acute Procedural Success	Percentage of subjects with successful revascularization of target vessel defined as ≤30% residual stenosis at the index lesion post AURYON™ atherectomy and final adjunctive treatment (if required), as evaluated by angiographic corelab.	Peri-procedural (by the end of the index procedure)
Primary Safety: Freedom from Peri-procedural major adverse events (PPMAE)	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.	Till discharge, an average of 5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of device related complications requiring intervention	Rate of device related complications requiring intervention, defined as peri procedural MAEs, reported by the operating physician as caused directly due to the use of the AURYON device.	Till discharge, an average of 5 days
Rates of MAEs over time	Rates of 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).	Post-discharge (at 30-days, 6-, 12-, and 24-months)
Patency rate	Patency rate, defined as <50% stenosis at the treated lesion, with peak systolic velocity ratio (PSVR) of <2.5, as assessed quantitatively by Duplex ultrasonography (DUS) performed in a lab that achieved Vascular Laboratory Accreditation, at 6, 12, and 24 months.	Post-discharge (at 6-, 12-, and 24-months)
Occlusion freedom	Only for BTK lesions: freedom from occlusion (100% stenosis by DUS) combined with freedom from CD-TLR	Post-discharge (at 6-, 12-, and 24-months)
Clinical outcome 1 - ankle brachial index (ABI)	Change in ankle brachial index (ABI or TBI if needed) at 6, 12, and 24, months, compared to baseline. Ankle-Brachial Index (ABI) si 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 & feet; 0.4-0.9 indicates mild-moderate PAD; 0.4 and lower indicates severe PAD. Positive difference between time-points represents a clinical improvement through time and vice versa.	Post-discharge (at 6-, 12-, and 24-months)
Clinical outcome 2 - walking impairment questionnaire (WIQ)	Change in walking impairment questionnaire (WIQ) score at 6, 12, and 24, months, compared to baseline. WIQ is a patient fulfilled survey to grade physical ability representing PAD progress, has 3 sub-scales (walking speed, distance, climbing stairs), when the total score ranges between 0-100, higher value = better outcome. Positive difference between time-points represents a clinical improvement through time and vice versa.	Post-discharge (at 6-, 12-, and 24-months)
Clinical outcome 3 - Rutherford clinical categories (RCC)	Change in Rutherford clinical category at 6, 12, and 24, months, compared to baseline. Rutherford Classification is a doctor determined 7 stages scale (0= Asymptomatic, 6= Severe ischemic ulcers/frank gangrene) representing PAD progress, lower value = better outcome. Positive difference between time-points represents a clinical deterioration through time and vice versa.	Post-discharge (at 6-, 12-, and 24-months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory endpoint: IVUS	Intravascular ultrasound assessment pre- and post-Auryon and correlation with angiographic findings (e.g. lesion length, MLA -minimal lumen area gain, calcium severity and removal, etc.). This endpoint will be analyzed only for cases that used IVUS as a routine practice in the index procedure.	Peri-procedural (by the end of the index procedure)

Collaborators and Investigators

• Sponsor: Angiodynamics, Inc.
• Investigators: Study Chair: TBD TBD

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2020
• Primary Completion (Actual): March 17, 2021
• Study Completion (Anticipated): April 17, 2023

Study Registration Dates

• First Submitted: January 10, 2020
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Observational Study; TBI; Peripheral Artery Disease; Registry; In-stent Restenosis; Real World Evidence; Chronic total occlusion; Intravascular ultrasound; CLI; ABI; Critical Limb Ischemia; Atherectomy; Intermittent Claudication; CTO; Acute Limb Ischemia; Peripheral Occlusive Disease; Peripheral Artery Stenonsis; Artery Restenosis; Arterial Occlusive Disease; Peripheral Vascular disease; Laser recanalization; Endovascular treatment or Procedure or Surgery; Calcified Lesions; Claudication pain; Arterial Calcification; Acute Arterial Occlusion; Infra-inguinal Stenosis or Occlusion; Femoral Artery Stenosis; Femoral-Popliteal Arterial Disease; Tibial Stenosis; Stenotic lesion; Peripheral Artery Revascularization; Lower Limb Arterial Calcification; Laser-assisted angioplasty; Above the Knee calcification; ATK Calcification; Below the Knee Calcification; Superficial Femoral Artery Disease; Target Lesion revascularization; Atherectomy Catheter; Walking Impairment questionnaire; Ankle-Brachial Pressure Index; Toe-Brachial Index; Rutherford Classification; Peak Systolic Velocity Ratio; Auryon System; Eximo Medical; AngioDynamics; B-Laser
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: EX-PAD-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No