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This study seeks to demonstrate the effectiveness and safety of the Non-valved Conduit for CE marking on the basis of infection. The rationale for infection resistance with the conduit is that BioIntegral Surgical No-React® treated products have a well-documented history of infection resistance in hybrid vascular settings.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No-React Non-valved Conduit | Device | Operative replacement of infected graft or implantation in infected area. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of graft infection 3 months after implantation | Percentage of graft infection 3 months after implantation as assessed with different infection parameters: CRP value, leukocytes, Samson classification of infection, temperature, wound healing, wound infection, purulence | 3 months after implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patency 12 months after implantation | Percentage of patency 12 months after implantation as assessed with duplex ultrasound or CT imaging. <50% stenosis are defined as patent | 12 months after implantation |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with (a high risk for) infection.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catharina Ziekenhuis | Eindhoven | Netherlands |
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