BPV-14-005. 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)
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- STATUS
- Not Recruiting
Summary
This is a prospective, multi-center, randomized, concurrently-controlled clinical study designed 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 AV access circuit of hemodialysis subjects dialyzing with an AV fistula. This study will compare the use of the COVERA Vascular Covered Stent (following percutaneous transluminal angioplasty (PTA)) to PTA alone.
Description
This is a prospective, multi-center, randomized, concurrently-controlled clinical study designed 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 AV access circuit of hemodialysis subjects dialyzing with an AV fistula. This study will compare the use of the COVERA Vascular Covered Stent (following percutaneous transluminal angioplasty (PTA)) to PTA alone.
Details
| Condition | fistula |
|---|---|
| Age | 18years - 100years |
| Clinical Study Identifier | TX7523 |
| Last Modified on | 19 February 2024 |
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