Trials / Completed
CompletedNCT02746159
Lutonix® Global AV Registry Investigating Lutonix Drug Coated Balloon for Treatment of Native and Synthetic AV Fistulae
A Prospective, Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon PTA Catheter for Treatment of Dysfunctional Native and Synthetic AV Fistulae
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 320 (actual)
- Sponsor
- C. R. Bard · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this Registry is to enroll patients presenting with clinical and hemodynamic abnormalities in native or synthetic (grafts) arteriovenous (AV) fistulae located in the arm. Subjects will be treated with the Lutonix DCB carrying the CE Mark per current IFU and followed clinically for a minimum of 12 months.
Detailed description
This post market registry is intended to demonstrate safety and assess the clinical use and outcomes of the Lutonix DCB in a heterogeneous patient population with dysfunctional native or synthetic AV fistulae in real world clinical practice.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Lutonix 035 Drug Coated Balloon PTA Catheter, Model 9004 |
Timeline
- Start date
- 2016-06-07
- Primary completion
- 2018-09-18
- Completion
- 2019-03-09
- First posted
- 2016-04-21
- Last updated
- 2023-02-22
Locations
26 sites across 13 countries: Austria, France, Germany, Greece, Italy, Poland, Portugal, Saudi Arabia, Singapore, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT02746159. Inclusion in this directory is not an endorsement.