Clinical trial NCT01977508: The Vascutek Rapidax™ II Post Market Surveillance Registry
Official title: The Vascutek Rapidax™ II Post Market Surveillance Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: End Stage Kidney Disease
Keywords: Vascular access grafts
Haemodialysis
Lead sponsor: Vascutek Ltd.
Sponsor class: INDUSTRY
First posted: 2013-11-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Safety and Performance
timeFrame: 6 months
measure: Safety and Performance
timeFrame: 12 months
measure: Safety and Performance
timeFrame: 12 months
Secondary outcomes:
measure: Safety and Performance
timeFrame: 6 months
measure: Safety and Performance
timeFrame: 12 months
measure: Safety and Performance
timeFrame: 12 months
measure: Safety and Performance
timeFrame: 12 months
Other outcomes:
Locations:
city: Naumburg
country: Germany
facility: Saale-Unstrut Klinikum Naumburg
city: Saale
country: Germany
facility: Thüringen Kliniken Georguis
city: Sonneberg
country: Germany
facility: Medinos Klinik Sonneberg
Study officials:
affiliation: Saale-Unstrut Klinikum Naumburg
name: Bernd Lobenstein
role: PRINCIPAL_INVESTIGATOR
References: