NCT01977508

The Vascutek Rapidax™ II Post Market Surveillance Registry

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: Vascutek Ltd. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Conditions

• End Stage Kidney Disease

Interventions

Type	Name	Description
DEVICE	ePTFE vascular access grafts

Timeline

• Start date: 2013-08-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2013-11-06
• Last updated: 2016-05-20

Locations

3 sites across 1 country: Germany