The Vascutek Rapidax™ II Post Market Surveillance Registry

Terminated

• Conditions: End Stage Kidney Disease
• Interventions: Device: ePTFE vascular access grafts

• Registration Number: NCT01977508
• Lead Sponsor: Vascutek Ltd.

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

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-10-15
• Study First Submitted QC: 2013-10-30
• Study First Posted: 2013-11-06
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-19
• Last Update Posted: 2016-05-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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

Exclusion Criteria

1. Known allergy or sensitivity to ePTFE
2. Subject unwilling or unable to comply with the protocol
3. Life expectancy of less than 1 year

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
haemodialysis vascular access using ePTFE grafts	ePTFE vascular access grafts	-

Primary Outcome Measures

Name	Time	Method
Safety and Performance	12 months	Freedom from device related Serious Adverse Events at 6 and 12 months (Safety)

Secondary Outcome Measures

Name	Time	Method
Safety and Performance	12 months	Freedom from device related Serious Adverse Events at 6 and 12 months

Trial Locations

Locations (3)

Thüringen Kliniken Georguis; 🇩🇪 Saale, Germany

Saale-Unstrut Klinikum Naumburg; 🇩🇪 Naumburg, Germany

Medinos Klinik Sonneberg; 🇩🇪 Sonneberg, Germany