Evaluation of WIRION™ EPS in Lower Extremities Arteries

Study Overview
=================
Brief Summary
-----------------
Demonstrate the safety and performance of the WIRION™ EPS in subjects undergoing lower extremity atherectomy for the treatment of Peripheral Arterial Disease (PAD)

Official Title
-----------------
Evaluation of WIRION™ EPS in Lower Extremities Arteries

Conditions
-----------------
Peripheral Arterial Disease (PAD)

Intervention / Treatment
-----------------
* Device: WIRION


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is at least 18 years of age Subject or authorized representative, signed a written Informed Consent form to participate in the study, prior to any study related procedures Subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations Rutherford classification 2-4 Has moderate to severe calcification visualized on angiogram in the femoropopliteal arteries Planned atherectomy of the native femoropopliteal arteries Reference vessel diameter for intended filter location must be visually estimated to be ≥3.5mm and ≤6.0mm An adequate landing zone for placement of the WIRION™ device distal to the target lesion of at least 30mm A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days and agrees to remain on birth control throughout the study Exclusion Criteria: Any planned surgical or endovascular intervention within 30 days before or after the index procedure A lesion deemed not accessible by the WIRION™ EPS Inability to take aspirin or ADP receptor antagonists History of bleeding diathesis or coagulopathy or will refuse blood transfusion if deemed necessary Has perforation, dissection, or other injury of the access or target vessel requiring additional stenting or surgical intervention before enrollment Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint (participating in registry studies is not excluded) Life expectancy less than 12 months Known severe renal insufficiency (eGFR <30 ml/min/1.72m2). ≤1-vessel tibial run-off status

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WIRION EPS<br>Single arm study. All patients undergo procedure with the WIRION EPS | Device: WIRION<br>* Embolic Protection System<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom From Major Adverse Events (MAE) to 30 Days Post Procedure. | MAE defined as a serious adverse event that results in death, acute myocardial infarction, thrombosis, pseudo-aneurysm, dissection (grade C or greater) or clinical perforation at the filter location, distal embolism (clinically relevant), unplanned amputation, or clinically-driven target vessel revascularization (TVR), through 30 days post-procedure, as adjudicated by the Clinical Events Committee (CEC) | 30 days |