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Trial of Pantheris System, an Atherectomy Device That Provides Imaging While Removing Plaque in Lower Extremity Arteries

NCT02126540 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-12-16

No results posted yet for this study

Summary

To evaluate the safety and effectiveness of the Pantheris System to perform atherectomy while using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque from diseased lower extremity arteries.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

Pantheris Atherectomy System

Treatment device in primary cohort arm; OCT image guided directional atherectomy

Sponsors & Collaborators

  • Avinger, Inc.

    lead INDUSTRY

Principal Investigators

  • Andreq Holden, MD · Auckland City Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-01-31
Completion
2016-07-31

Countries

  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02126540 on ClinicalTrials.gov