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Safety and Effectiveness of B-Laser™ in Subjects Affected With Infrainguinal PAD

NCT03157531 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2019-06-20

Study results available
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Summary

This is a prospective, single-arm, multi-center, international, open-label, clinical study.

Conditions

  • PAD

Interventions

DEVICE

B-Laser™ Atherectomy System

The B-Laser™ is indicated for use for atherectomy of infrainguinal stenoses

Sponsors & Collaborators

  • Eximo Medical Ltd.

    lead INDUSTRY

Principal Investigators

  • John Rundback, Dr. · Holy Name Medical Center, Teaneck, New Jersey, United States, 07666

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-06
Primary Completion
2018-04-27
Completion
2018-10-11
FDA Device
Yes

Countries

  • United States
  • Austria
  • Italy

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 NCT03157531 on ClinicalTrials.gov