Prospective Multicenter Non-randomized Single Arm Clinical Trial to Evaluate the Safety and Efficacy of e-PTFE Grafts Inner Surface-treated With Paclitaxel as an Access for Hemodialysis in Patients With End-stage Renal Disease.
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- STATUS
- Recruiting
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- participants needed
- 20
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- sponsor
- Samsung Medical Center
Summary
This prospective, multicenter, non-randomized, single-arm Clinical trial aims to evaluate the safety and effectiveness of the use of paclitaxel-coated arteriovenous graft (AVG) on the inner wall of ePTFE graft, which is designed to reduce neointimal hyperplasia that causes stenosis and thrombosis after implantation of AVG.
Description
- Evaluation of safety Primary outcome: all adverse events occurring in the subject
- Evaluation of effectiveness Primary outcome: AV graft primary patency Secondary outcome: AV graft secondary patency
Details
| Condition | Hemodialysis Access Failure |
|---|---|
| Age | 20-80 years |
| Treatment | Paclitaxel-eluting graft |
| Clinical Study Identifier | NCT04285073 |
| Sponsor | Samsung Medical Center |
| Last Modified on | 19 February 2024 |
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