Assessment of the Utility of the Pantheris Small Vessel (SV) System

Status Recruiting

Clinical Trial Summary

A single-arm study to assess the utility of the Pantheris SV catheter in addressing peripheral artery disease in arteries located below the knee. Data will be collected on the percent stenosis pre- and post-atherectomy and then symptoms and adverse events noted at 30 days, 6 months, and 1 year after the procedure.

Clinical Trial Description

This is a post-market, single-arm study of the optical coherence tomography (OCT)-guided directional atherectomy catheter, Pantheris SV. Patients presenting with reduced blood flow in the lower extremity arteries will under directional atherectomy, followed by adjunctive therapy as deemed necessary by the physician, and then adverse events and symptom resolution will be documented at 30 days, 6 months, and 1 year after the procedure. Primary safety endpoints are related to adverse events and will be assessed at the time of the procedure and at 30 days after the procedure. Effectiveness endpoints center on restoration of blood flow. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04793581
Study type	Interventional
Source	Avinger, Inc.
Contact	Thomas Lawson, PhD
Phone	6502417030
Email	tlawson@avinger.com
Status	Recruiting
Phase	N/A
Start date	January 29, 2021
Completion date	August 1, 2024

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