Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that has completed, run by C. R. Bard. The registered enrollment target is 285 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02440022
The ClinicalTrials.gov registry entry for NCT02440022 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 285 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is C. R. Bard, which has 75 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Lutonix DCB is the first listed.
NCT02440022 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.