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Lutonix Global SFA Registry

NCT01864278 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 691

Last updated 2016-11-08

No results posted yet for this study

Summary

The registry will enroll patients with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery. Subjects will be treated with the LUTONIX Drug Coated PTA Dilatation Catheter carrying the CE Mark per current Instructions for Use(IFU) and followed clinically for a minimum of 2 years.

Conditions

Interventions

DEVICE

Lutonix Drug Coated Balloon

Subject will receive treatment with the Lutonix Drug Coated Balloon

Sponsors & Collaborators

  • Bard Ltd

    collaborator INDUSTRY

  • C. R. Bard

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2015-07-31
Completion
2016-09-30

Countries

  • Austria
  • Belgium
  • France
  • Germany
  • Greece
  • Italy
  • Poland
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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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 NCT01864278 on ClinicalTrials.gov