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Lutonix® Global AV Registry Investigating Lutonix Drug Coated Balloon for Treatment of Native and Synthetic AV Fistulae

NCT02746159 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 320

Last updated 2023-02-22

No results posted yet for this study

Summary

The purpose of this Registry is to enroll patients presenting with clinical and hemodynamic abnormalities in native or synthetic (grafts) arteriovenous (AV) fistulae located in the arm. Subjects will be treated with the Lutonix DCB carrying the CE Mark per current IFU and followed clinically for a minimum of 12 months.

Conditions

  • Arteriovenous Fistula

Interventions

DEVICE

Lutonix 035 Drug Coated Balloon PTA Catheter, Model 9004

Sponsors & Collaborators

  • C. R. Bard

    lead INDUSTRY

Principal Investigators

  • Dimitrios Karnabatidis, MD, PhD · University Hospital of Patras, Radiology Department

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-07
Primary Completion
2018-09-18
Completion
2019-03-09

Countries

  • Austria
  • France
  • Germany
  • Greece
  • Italy
  • Poland
  • Portugal
  • Saudi Arabia
  • Singapore
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

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 NCT02746159 on ClinicalTrials.gov