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Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon for Treatment of BTK Arteries

NCT02554266 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 371

Last updated 2020-01-13

No results posted yet for this study

Summary

The study will enroll patients presenting with claudication, or critical limb ischemia (Rutherford Category 3- 5) and an angiographically significant (≥ 70%) native artery lesion appropriate for angioplasty that is below the knee. Subjects will be treated with the Lutonix Drug Coated Balloon (DCB) carrying the CE Mark per current IFU and followed clinically for a minimum of 2 years.

Conditions

Interventions

DEVICE

Lutonix 014 Drug Coated Balloon PTA Catheter

Drug Coated Balloon PTA Catheter for Treatment of Below-the-Knee (BTK) Arteries

Sponsors & Collaborators

  • C. R. Bard

    lead INDUSTRY

Principal Investigators

  • Dierk Scheinert, MD · Universitätsklinikum Leipzig: Angiologie

  • Michael Lichtenberg, MD · Klinikum Arnsberg

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-29
Primary Completion
2018-05-31
Completion
2019-11-22

Countries

  • Austria
  • Belgium
  • France
  • Germany
  • Greece
  • Italy
  • Portugal
  • Saudi Arabia
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT02554266 on ClinicalTrials.gov