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

Active, not recruiting

• Conditions: Infrainguinal Peripheral Artery Disease; PAD; Peripheral Arterial Disease
• Interventions: Device: AURYON™ System

• Registration Number: NCT04229563
• Lead Sponsor: Angiodynamics, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2020-01-10
• Study First Submitted QC: 2020-01-13
• Study First Posted: 2020-01-18
• Study Start: 2020-08-04
• Primary Completion: 2021-03-17
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-16
• Last Update Posted: 2023-02-21
• Study Completion: 2023-04-17

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 104

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).

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study patients	AURYON™ System	Eligible PAD patients who are routinely treated with atherectomy by AURYON™ Atherectomy System.

Primary Outcome Measures

Name	Time	Method
Primary Efficacy: Acute Procedural Success	Peri-procedural (by the end of the index procedure)	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.
Primary Safety: Freedom from Peri-procedural major adverse events (PPMAE)	Till 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 Outcome Measures

Name	Time	Method
Rate of device related complications requiring intervention	Till discharge, an average of 5 days	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.
Rates of MAEs over time	Post-discharge (at 30-days, 6-, 12-, and 24-months)	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).
Patency rate	Post-discharge (at 6-, 12-, and 24-months)	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.
Occlusion freedom	Post-discharge (at 6-, 12-, and 24-months)	Only for BTK lesions: freedom from occlusion (100% stenosis by DUS) combined with freedom from CD-TLR
Clinical outcome 1 - ankle brachial index (ABI)	Post-discharge (at 6-, 12-, and 24-months)	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.
Clinical outcome 2 - walking impairment questionnaire (WIQ)	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 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.
Clinical outcome 3 - Rutherford clinical categories (RCC)	Post-discharge (at 6-, 12-, and 24-months)	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.

Trial Locations

Locations (5)

Pulse Cardiovacular; 🇺🇸 Scottsdale, Arizona, United States

Comprehensive Cardiovascular; 🇺🇸 Davenport, Florida, United States

Hurricane Cardiology; 🇺🇸 New Braunfels, Texas, United States

Pima Vascular; 🇺🇸 Tucson, Arizona, United States

Midwest Cardio. research foundation; 🇺🇸 Davenport, Iowa, United States