The Vascutek Rapidax™ II Post Market Surveillance Registry

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.

Study Overview

• Status: Terminated
• Conditions: End Stage Kidney Disease
• Intervention / Treatment: Device: ePTFE vascular access grafts

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 Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• Germany
  • Naumburg, Germany
    • Saale-Unstrut Klinikum Naumburg
  • Saale, Germany
    • Thüringen Kliniken Georguis
  • Sonneberg, Germany
    • MEDINOS Klinik Sonneberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
haemodialysis vascular access using ePTFE grafts	Device: ePTFE vascular access grafts; Other Names: RapidaxTM II Vascular access graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Performance	Secondary patency at 6 months post implant (Performance)	6 months
Safety and Performance	Secondary patency at 12 months post implant (Performance)	12 months
Safety and Performance	Freedom from device related Serious Adverse Events at 6 and 12 months (Safety)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Performance	Primary patency at 6 months post implant (Performance)	6 months
Safety and Performance	Primary patency at 12 months post implant (Performance) •	12 months
Safety and Performance	Assisted primary patency at 6 months (Performance) •	12 months
Safety and Performance	Freedom from device related Serious Adverse Events at 6 and 12 months	12 months

Collaborators and Investigators

• Sponsor: Vascutek Ltd.
• Investigators: Principal Investigator: Bernd Lobenstein, Saale-Unstrut Klinikum Naumburg

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: October 15, 2013
• First Submitted That Met QC Criteria: October 30, 2013
• First Posted (Estimate): November 6, 2013

Study Record Updates

• Last Update Posted (Estimate): May 20, 2016
• Last Update Submitted That Met QC Criteria: May 19, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Vascular access grafts; Haemodialysis
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: VAG-001