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Post Approval Study Investigating Lutonix Drug Coated Balloon for Treatment of Dysfunctional Arteriovenous Fistulae

NCT03506308 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2026-03-18

No results posted yet for this study

Summary

This prospective, global, multicenter, single arm post-approval study is designed to investigate the clinical use and safety of the Lutonix® 035 AV Drug Coated Balloon (DCB) PTA Catheter in subjects presenting with clinical and hemodynamic abnormalities in native arteriovenous (AV) fistulae located in the upper extremity.

Conditions

  • Arteriovenous Fistula

Interventions

DEVICE

LUTONIX 035 Drug Coated Balloon PTA Catheter

All subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.

Sponsors & Collaborators

  • C. R. Bard

    lead INDUSTRY

Principal Investigators

  • Scott Trerotola, MD · Hospital of the University of Pennsylvania; Division of Interventional Radiology

  • Dheeraj Rajan, MD · University Health Network; Division of Vascular & Interventional Radiology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-07
Primary Completion
2027-04-30
Completion
2030-04-30
FDA Device
Yes

Countries

  • United States
  • Canada

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 NCT03506308 on ClinicalTrials.gov