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Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries

NCT01870401 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 442

Last updated 2022-02-09

Study results available
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Summary

To assess the safety and efficacy of the Lutonix Drug Coated Balloon (DCB) for treatment of stenosis or occlusion of native below-the-knee arteries.

Conditions

  • Critical Limb Ischemia

Interventions

DEVICE

Lutonix DCB

DEVICE

Uncoated PTA Catheter

Sponsors & Collaborators

  • Bard Ltd

    collaborator INDUSTRY

  • C. R. Bard

    lead INDUSTRY

Principal Investigators

  • Patrick Geraghty, MD · Washington University School of Medicine

  • Jihad Mustapha, MD · Metro Health Hospital

  • Marianne Brodmann, MD · Medical University Graz, Austria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-03
Primary Completion
2018-05-17
Completion
2021-06-22
FDA Device
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Germany
  • Italy
  • Japan
  • Switzerland

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 NCT01870401 on ClinicalTrials.gov