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Safety and Effectiveness Study of Eximo's B-Laser™ Atherectomy Device for PAD Treatment

NCT02556255 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2021-03-03

Study results available
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Summary

The aim of the study is to assess the safety and efficacy of the use of the Eximo's B-Laser™ catheter in subjects affected with Peripheral Artery Disease (PAD) in lower extremity arteries.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

B-Laser™ Atherectomy Catheter

Laser atherectomy catheter based on 355 nm

Sponsors & Collaborators

  • KCRI

    collaborator OTHER

  • Eximo Medical Ltd.

    lead INDUSTRY

Principal Investigators

  • Oshrat Cohen, Ph.D., MBA · Angiodynamics, Inc.

  • Waclaw Kuczmik, Dr. · Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach

  • Grzegorz Oszkinis, Prof. · Poznan Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im.Karola Marcinkowskiego

  • Lukasz Dzieciuchowicz, Prof · Poznan Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im.Karola Marcinkowskiego

  • Lukasz Kruszyna, Prof · Poznan Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im.Karola Marcinkowskiego

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-08-31
Completion
2020-11-20

Countries

  • Poland

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 NCT02556255 on ClinicalTrials.gov