# Study Comparing Lutonix AV Drug Coated Balloon vs Standard Balloon for Treatment of Dysfunctional AV Fistulae

> **NCT02440022** · PHASE3 · COMPLETED · sponsor: **C. R. Bard** · enrollment: 285 (actual)

## Conditions studied

- Arteriovenous Fistula

## Interventions

- **COMBINATION_PRODUCT:** Lutonix DCB
- **DEVICE:** Standard Balloon Angioplasty Catheter
- **PROCEDURE:** Percutaneous Transluminal Angiography

## Key facts

- **NCT ID:** NCT02440022
- **Lead sponsor:** C. R. Bard
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2015-06
- **Primary completion:** 2016-09
- **Final completion:** 2018-06
- **Target enrollment:** 285 (ACTUAL)
- **Last updated:** 2020-05-06


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02440022

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02440022, "Study Comparing Lutonix AV Drug Coated Balloon vs Standard Balloon for Treatment of Dysfunctional AV Fistulae". Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/clinical/NCT02440022. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
