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Multicentre, prospective, observational post-market registry. To monitor and collect data on the post-market clinical safety and performance of the Vascutek Rapidax II Vascular Access Graft.
At least 10 patients who have been implanted with a Rapidax II Vascular Access Graft for haemodialysis applications in patients with End Stage Renal Disease (ESRD), who are undergoing or are scheduled to begin haemodialysis and require implant of a prosthetic graft.
Primary End Points:Safety and Performance
Secondary End Points: Safety and performance
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| haemodialysis vascular access using ePTFE grafts |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ePTFE vascular access grafts | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Performance |
| 6 months |
| Safety and Performance | Secondary patency at 12 months post implant (Performance) | 12 months |
| Safety and Performance | Freedom from device related Serious Adverse Events at 6 and 12 months (Safety) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Performance |
| 6 months |
| Safety and Performance | Primary patency at 12 months post implant (Performance) • |
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Inclusion Criteria:
Exclusion Criteria:
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At least 10 patients who have been implanted with a Rapidax II Vascular Access Graft for haemodialysis applications in patients with End Stage Renal Disease (ESRD), who are undergoing or are scheduled to begin haemodialysis and require implant of a prosthetic graft.
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| Name | Affiliation | Role |
|---|---|---|
| Bernd Lobenstein | Saale-Unstrut Klinikum Naumburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saale-Unstrut Klinikum Naumburg | Naumburg | Germany | ||||
| Thüringen Kliniken Georguis |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| 12 months |
| Safety and Performance | Assisted primary patency at 6 months (Performance) • | 12 months |
| Safety and Performance | Freedom from device related Serious Adverse Events at 6 and 12 months | 12 months |
| Saale |
| Germany |
| Medinos Klinik Sonneberg | Sonneberg | Germany |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |