The Pathway PVD Study for Percutaneous Peripheral Vascular Interventions

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.

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Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pathway PV Atherectomy System

Device

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.

Primary outcomes

Major Adverse Events (MAEs) Within 30 Days

Time frame: 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.

Secondary outcomes

Average Rutherford Classification Score at 6 Months

Time frame: 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)
Average Ankle Brachial Index (ABI) at 6 Months

Time frame: 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)
Freedom From Target Lesion Revascularization (TLR) at 6 Months

Time frame: 6 months

Number of patients that did not require target lesion revascularization 6 months after index procedure.

Sponsors and collaborators

Lead sponsor

Pathway Medical Technologies Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2008
First posted: May 13, 2008
Registry last updated: Jul 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed