The Vascutek Rapidax™ II Post Market Surveillance Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2016-05-31

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.

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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

Conditions

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End Stage Kidney Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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haemodialysis vascular access using ePTFE grafts

ePTFE vascular access grafts

Intervention Type DEVICE

Interventions

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ePTFE vascular access grafts

Intervention Type DEVICE

Other Intervention Names

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RapidaxTM II Vascular access graft

Eligibility Criteria

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Inclusion Criteria

1. Subject is ≥ 18 and ≤ 90 years old
2. Subject has a life expectancy of at least 12 months
3. Subject is scheduled to undergo placement of a new straight or loop arm arteriovenous haemodialysis access graft
4. The subject is willing and able to comply with the protocol and associated follow up requirements
5. Subjects must have agreed for their data to be entered into the registry as per the local hospital consent procedure