The Vascutek Rapidax™ II Post Market Surveillance Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Primary End Points:Safety and Performance Secondary patency at 6 months post implant (Performance).(access survival until abandonment). The interval from time of implant to abandonment or time of measurement of patency, including intervention to re-establish the functionality of the thrombosed access Secondary patency at 12 months post implant (Performance.(access survival until abandonment). The interval from time of implant to abandonment or time of measurement of patency, including intervention to re-establish the functionality of the thrombosed access Freedom from device related Serious Adverse Events at 6 and 12 months (Safety) Secondary End Points: Safety and performance Primary patency at 6 months post implant (Performance. (intervention free access survival). The interval from time of implant to any intervention designed to maintain or re-establish patency or to access thrombosis Primary patency at 12 months post implant (Performance).(intervention free access survival). The interval from time of implant to any intervention designed to maintain or re-establish patency or to access thrombosis Assisted primary patency at 6 months (Performance. (thrombosis free access survival). The interval from time of implant to intervention to maintain patency prior to the occurrence of thrombosis Freedom from device related Serious Adverse Events at 6 and 12 months

Official Title
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The Vascutek Rapidax™ II Post Market Surveillance Registry

Conditions
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End Stage Kidney Disease

Intervention / Treatment
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* Device: ePTFE vascular access grafts


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is ≥ 18 and ≤ 90 years old Subject has a life expectancy of at least 12 months Subject is scheduled to undergo placement of a new straight or loop arm arteriovenous haemodialysis access graft The subject is willing and able to comply with the protocol and associated follow up requirements Subjects must have agreed for their data to be entered into the registry as per the local hospital consent procedure Exclusion Criteria: Known allergy or sensitivity to ePTFE Subject unwilling or unable to comply with the protocol Life expectancy of less than 1 year

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| haemodialysis vascular access using ePTFE grafts<br> | Device: ePTFE vascular access grafts<br> <br> * Other names: RapidaxTM II Vascular access graft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Performance | Secondary patency at 6 months post implant (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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Performance | Primary patency at 6 months post implant (Performance) | 6 months | 
| Safety and Performance | Primary patency at 12 months post implant (Performance) • | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vascular access grafts, Haemodialysis