The Pathway PVD Study for Percutaneous Peripheral Vascular Interventions

Pathway Medical Technologies

Status

Completed

Conditions

Peripheral Artery Disease

Treatments

Device: Pathway PV Atherectomy System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00676494

PTC 05003

Details and patient eligibility

About

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.

Enrollment

172 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.