At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 285 enrolled

Drug / intervention

Lutonix DCB +2 morecombination

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02440022

NCT02440022Phase 3Completed

Compare CT.gov

A Prospective, Global, Multicenter, Randomized, Controlled Study Comparing Lutonix® 035 AV Drug Coated Balloon PTA Catheter vs. Standard Balloon PTA Catheter for the Treatment of Dysfunctional AV Fistulae

C. R. Bard·interventional·Posted May 12, 2015·Updated May 6, 2020

In Brief

A Phase 3 clinical trial evaluating Lutonix DCB, Standard Balloon Angioplasty Catheter, and 1 other intervention for Arteriovenous Fistula. Completed, enrolled 285 participants across 23 sites.

Detailed Summary

This prospective, global, multicenter, randomized, controlled study is designed to evaluate the safety and effectiveness of the Lutonix 035 AV Drug Coated Balloon PTA Catheter compared to a standard PTA Catheter in treating subjects presenting with clinical and hemodynamic abnormalities in native arteriovenous (AV) fistulae located in the upper extremity.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsArteriovenous Fistula

CountriesUnited States

Collaborators--

Timeline

Phase 3CompletedFinished

20162017201820192020202120222023202420252026

First PostedMay 2015

Enrollment StartJun 2015

Primary CompletionSep 2016

Study CompletionJun 2018

TodayJul 2026

First PostedMay 12, 2015

Enrollment StartJun 1, 2015

Primary CompletionSep 1, 2016

Study CompletionJun 1, 2018

TodayJul 2, 2026

Enrollment to primary: 1.3 yearsPosted 11.1 years ago

Interventions

Lutonix DCBcombination

Standard Balloon Angioplasty Catheterdevice

Percutaneous Transluminal Angiographyprocedure

Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.