The Vascutek Rapidax™ II Post Market Surveillance Registry
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- End Stage Kidney Disease
- Sponsor
- Vascutek Ltd.
- Enrollment
- 24
- Locations
- 3
- Primary Endpoint
- Safety and Performance
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
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
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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Safety and Performance
Time Frame: 12 months
Freedom from device related Serious Adverse Events at 6 and 12 months (Safety)
Secondary Outcomes
- Safety and Performance(12 months)