The Pathway PVD Study for Percutaneous Peripheral Vascular Interventions

Pathway Medical Technologies Inc.172 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

172

Conditions

Peripheral Artery Disease

Interventions

Pathway PV Atherectomy SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 30 days

Secondary Outcomes

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)

Time frame: 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)

Time frame: 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.

Time frame: 6 months

Data from ClinicalTrials.gov

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