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Paclitaxel Coated PTA Balloons for Treatment of Dysfunctional AV Fistulae and Grafts

NCT02183194 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-02-02

No results posted yet for this study

Summary

The purpose of this study is to evaluate the Lutonix® 035 Drug Coated Balloon PTA Catheter (CE mark) for use as intended in the treatment of subjects with clinically significant hemodialysis vascular access stenosis or occlusion.

Conditions

  • Dysfunctional AV Graft
  • Dysfunctional AV Fistula

Interventions

DEVICE

Lutonix Paclitaxel Drug Coated Balloon

Sponsors & Collaborators

  • C. R. Bard

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Austria
  • Germany

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 NCT02183194 on ClinicalTrials.gov