The Vascutek Rapidax™ II Post Market Surveillance Registry

End Stage Kidney Disease Clinical Trial

Official title:

The Vascutek Rapidax™ II Post Market Surveillance Registry

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01977508
• Other study ID #: VAG-001
• Status: Terminated
• Phase: N/A
• First received: October 15, 2013
• Last updated: May 19, 2016
• Start date: August 2013
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Vascutek Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• End Stage Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Device:
• ePTFE vascular access grafts

Locations

Country	Name	City	State
Germany	Saale-Unstrut Klinikum Naumburg	Naumburg
Germany	Thüringen Kliniken Georguis	Saale
Germany	Medinos Klinik Sonneberg	Sonneberg

Sponsors (1)

Lead Sponsor	Collaborator
Vascutek Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Performance	Secondary patency at 6 months post implant (Performance)	6 months	Yes
Primary	Safety and Performance	Secondary patency at 12 months post implant (Performance)	12 months	Yes
Primary	Safety and Performance	Freedom from device related Serious Adverse Events at 6 and 12 months (Safety)	12 months	Yes
Secondary	Safety and Performance	Primary patency at 6 months post implant (Performance)	6 months	Yes
Secondary	Safety and Performance	Primary patency at 12 months post implant (Performance); •	12 months	Yes
Secondary	Safety and Performance	Assisted primary patency at 6 months (Performance); •	12 months	Yes
Secondary	Safety and Performance	Freedom from device related Serious Adverse Events at 6 and 12 months	12 months	Yes