Trials / Completed
CompletedNCT02649946
Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft
A Prospective, Multi-Center, Randomized, Concurrently-Controlled Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft in the Treatment of Stenosis in the Venous Outflow of AV Fistula Access Circuits (AVeNEW)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 280 (actual)
- Sponsor
- C. R. Bard · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to assess the safety and effectiveness of the COVERA™ Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the Arteriovenous (AV) access circuit.
Detailed description
This study will compare the use of the COVERA™ Vascular Covered Stent (following percutaneous transluminal angioplasty (PTA)) to PTA alone for the treatment of stenotic lesions in the upper extremity venous outflow of the arteriovenous (AV) access circuit of subjects dialyzing with an AV fistula.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Covera Vascular Covered Stent following PTA | Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent. |
| PROCEDURE | Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon | Treatment of stenoses with PTA only |
Timeline
- Start date
- 2016-06-01
- Primary completion
- 2018-08-01
- Completion
- 2021-02-01
- First posted
- 2016-01-08
- Last updated
- 2021-12-21
- Results posted
- 2019-05-13
Locations
24 sites across 8 countries: United States, Australia, Austria, Belgium, Germany, Netherlands, New Zealand, Switzerland
Source: ClinicalTrials.gov record NCT02649946. Inclusion in this directory is not an endorsement.