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

Study Overview
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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.

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.

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

Conditions
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Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease, PAD

Intervention / Treatment
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* Device: AURYON™ System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CTO, Tibial Stenosis, Peripheral Artery Disease, Peripheral Occlusive Disease, Peripheral Artery Stenonsis, Artery Restenosis, Arterial Occlusive Disease, Peripheral Vascular disease, Laser recanalization, Endovascular treatment or Procedure or Surgery, Calcified Lesions, Atherectomy, Intermittent Claudication, Claudication pain, Arterial Calcification, Critical Limb Ischemia, CLI, Acute Limb Ischemia, Acute Arterial Occlusion, Infra-inguinal Stenosis or Occlusion, Femoral Artery Stenosis, Femoral-Popliteal Arterial Disease, In-stent Restenosis, Stenotic lesion, Peripheral Artery Revascularization, Lower Limb Arterial Calcification, Laser-assisted angioplasty, Above the Knee calcification, ATK Calcification, Below the Knee Calcification, Chronic total occlusion, Superficial Femoral Artery Disease, Target Lesion revascularization, Atherectomy Catheter, Observational Study, Registry, Walking Impairment questionnaire, Intravascular ultrasound, Ankle-Brachial Pressure Index, Toe-Brachial Index, Rutherford Classification, ABI, TBI, Peak Systolic Velocity Ratio, Auryon System, Eximo Medical, AngioDynamics, B-Laser, Real World Evidence