Study Comparing Lutonix AV Drug Coated Balloon vs Standard Balloon for Treatment of Dysfunctional AV Fistulae
Public ClinicalTrials.gov record NCT02440022. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT02440022
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 285 participants
Conditions and interventions
Conditions
Interventions
- Lutonix DCB Combination Product
- Standard Balloon Angioplasty Catheter Device
- Percutaneous Transluminal Angiography Procedure
Combination Product · Device · Procedure
Eligibility (public fields only)
- Age range
- 21 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 2015 (Type not available)
- Primary completion
- Sep 2016 (Actual)
- Completion
- Jun 2018 (Actual)
- Last update posted
- May 6, 2020
2015 – 2018
United States locations
- U.S. sites
- 23
- U.S. states
- 17
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Board of Trustees of The University of Alabama for the University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Arizona Kidney Disease and Hypertension Center Medical Research Services, LLC | Phoenix | Arizona | 85012 | — |
| Southwest Clinical Research Institute, LLC | Tempe | Arizona | 85284 | — |
| Capital Nephrology Medical Group | Sacramento | California | 95825 | — |
| Nephrology Associates, P.A. | Newark | Delaware | 19713 | — |
| Rush University | Chicago | Illinois | 60612 | — |
| RenalCare Associates, S.C. d/b/a Illinois Kidney Disease & Hypertension Center | Peoria | Illinois | 61603 | — |
| MakrisMD, LLC, d/b/a Chicago Access Care | Westmont | Illinois | 60559 | — |
| Massachusetts General Physicians Organizations, Inc. | Boston | Massachusetts | 02114 | — |
| Renal and Transplant Associates of New England, PC | Springfield | Massachusetts | 01107 | — |
| Michigan Vascular Center | Flint | Michigan | 48507 | — |
| Minnesota Vascular Surgery Center | New Brighton | Minnesota | 55112 | — |
| Capital Nephrology Associates, P.A. | Raleigh | North Carolina | 27610 | — |
| Oklahoma Life Access, PLLC | Tulsa | Oklahoma | 74104 | — |
| Trustees of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Providence Interventional Associates, LLC | Providence | Rhode Island | 02906 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Spartanburg Regional Health Services District, Inc. | Spartanburg | South Carolina | 29303 | — |
| University Vascular Access | Memphis | Tennessee | 38115 | — |
| Tarrant Vascular Clinic | Fort Worth | Texas | 76104 | — |
| San Antonio Kidney Disease Center Physicians Group, PLLC | San Antonio | Texas | 78215 | — |
| University of Virginia | Charlottesville | Virginia | 22908 | — |
| Board of Regents of the University of Wisconsin System | Madison | Wisconsin | 53715 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02440022, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 6, 2020 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02440022 live on ClinicalTrials.gov.