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Evaluation of the Pantheris Atherectomy System

NCT01937351 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2021-03-25

Study results available
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Summary

A non-randomized, prospective, global clinical trial of the Avinger Pantheris System, an atherectomy device that provides directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque in diseased lower extremity arteries.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

Pantheris System

Atherectomy using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque from diseased lower extremity arteries.

Sponsors & Collaborators

  • Avinger, Inc.

    lead INDUSTRY

Principal Investigators

  • Gray Bennett, MD · Jackson Heart Clinic

  • Billy Crowder, MD · Jackson Heart Clinic

  • Arne Schwindt, MD · Muenster 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
2013-06-25
Primary Completion
2015-07-15
Completion
2015-09-20
FDA Device
Yes

Countries

  • United States
  • Germany

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 NCT01937351 on ClinicalTrials.gov