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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel-eluting graft | Experimental | Single-arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel-eluting graft | Device | Implantation of e-PTFE Grafts inner surface-treated with paclitaxel as access for hemodialysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | All adverse events occurring in the subject | Up to 2 years after implantation of AVG |
| Primary patency | Percentage of no intervention (intravascular or surgical) to maintain or recover blood flow or occurrence to access thrombosis | at 6 months after implantation of AVG |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary patency | Percentage of no permanent failure of AVG | Up to 2 years after implantation of AVG |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| DaeJoong Kim | Contact | 82234103441 | daejoongsmc.kim@samsung.com | |
| Dae Joong Kim | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Dae Joong Kim | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | 135-710 | South Korea |
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