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NCT02440022 · ClinicalTrials.gov registry record · Phase 3
Study Comparing Lutonix AV Drug Coated Balloon vs Standard Balloon for Treatment of Dysfunctional AV Fistulae
A Phase 3 study, sponsored by C. R. Bard.
- Completed
- Registry status
- Phase 3
- Development phase
- 285
- Enrollment target
NCT02440022: Completed Phase 3 study, sponsored by C. R. Bard.
NCT02440022 is a Phase 3 study that has completed, run by C. R. Bard. The registered enrollment target is 285 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02440022, a Phase 3 study, has completed, sponsored by C. R. Bard.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 285 participants
- Enrollment target
Study 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.
Primary Outcome
Primary Patency is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis. Target Lesion Primary Patency (TLPP) ends with a clinically driven re-intervention of the target lesion or access thrombosis.
Interventions
- COMBINATION_PRODUCT Lutonix DCB
- DEVICE Standard Balloon Angioplasty Catheter
- PROCEDURE Percutaneous Transluminal Angiography
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 285 participants |
| Start Date | 2015-06 |
| Est. Completion | 2018-06 |
| Phase | Phase 3 |
What the finished NCT02440022 record still lists
NCT02440022 is an interventional study that assigns participants to a tested intervention. The registered 285 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 3 interventions - of which Lutonix DCB is the first listed.
NCT02440022 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02440022 about?
NCT02440022 is a clinical study titled "Study Comparing Lutonix AV Drug Coated Balloon vs Standard Balloon for Treatment of Dysfunctional AV Fistulae". 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 ar...
What is the current status of trial NCT02440022?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 285 participants. The study started on 2015-06. Estimated completion is 2018-06.
What interventions are being tested in trial NCT02440022?
The interventions under investigation include: Lutonix DCB (COMBINATION_PRODUCT), Standard Balloon Angioplasty Catheter (DEVICE), Percutaneous Transluminal Angiography (PROCEDURE).
Who is sponsoring clinical trial NCT02440022?
This trial is sponsored by C. R. Bard, which has 75 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02440022's enrollment target sits among peer trials
285 1185th of 2000 higher than 812 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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