The Pathway PVD Study for Percutaneous Peripheral Vascular Interventions

Study Overview
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Brief Summary
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The Pathway PV Atherectomy System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic debris and thrombus in peripheral vasculature. This is a prospective, single arm, multi-center study to obtain safety and performance data for the Pathway PV Atherectomy System when used as a primary or adjunctive therapy for percutaneous intervention to remove atherosclerotic disease, debris, and thrombus from the lower limb peripheral vasculature.

Official Title
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A Prospective, Single Arm, Multi-Center Study to Assess Performance of the Pathway PV Atherectomy System During Percutaneous Peripheral Vascular (PV) Interventions

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Device: Pathway PV Atherectomy System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented symptomatic atherosclerotic peripheral vascular disease Target lesion(s) is/are located in a superficial femoral, popliteal and/or infrapopliteal arteries The patient has been informed of the nature of the study and has provided informed consent The patient agrees and has capability to meet study requirements and be present at the follow-up clinic visits Exclusion Criteria: Target lesion is located in the iliac artery. Target lesion stenosis is < 70%. Interventional treatment is intended for in-stent restenosis at the peripheral vascular site. Patient is unable to participate for the duration of the study. Patient is currently participating or has participated in a study with another investigational medical device or medication.

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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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Pathway PV Atherectomy System|The Pathway PV Atherectomy System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic debris and thrombus in lower limb peripheral vasculature during percutaneous interventional procedures.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Events (MAEs) Within 30 Days | Major adverse events (MAEs) are any death, target vessel revascularization (TVR), target lesion revascularization (TLR), myocardial infarction (MI), or amputation of the treated limb that occurred within 30 days of the index procedure. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Rutherford Classification Score at 6 Months | Rutherford Classification measures lower limb peripheral arterial disease (PAD) by evaluating and rating symptoms. Score: 0 (no symptoms or discomfort in leg) to 6 (Tissue loss or gangrene in leg) | 6 months | 
| Average Ankle Brachial Index (ABI) at 6 Months | Ankle Brachial Index (ABI) is the ratio of the blood pressure in the lower legs to the blood pressure in the arms. Compared to the arm, lower blood pressure in the leg is a symptom of peripheral artery disease (PAD). Range: Normal arteries (1.0 - 1.2) to Severe arterial disease (under 0.5) | 6 months | 
| Freedom From Target Lesion Revascularization (TLR) at 6 Months | Number of patients that did not require target lesion revascularization 6 months after index procedure. | 6 months |