End Stage Kidney DiseaseNCT01977508
The Vascutek Rapidax™ II Post Market Surveillance Registry
An observational study of End Stage Kidney Disease, run by Vascutek Ltd. at 3 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- End Stage Kidney Disease
- What is being tested?
- ePTFE vascular access grafts
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 3 sitesGermany
- Study dates
- Aug 2013to May 2016
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Subject is ≥ 18 and ≤ 90 years old
- Subject has a life expectancy of at least 12 months
- Subject is scheduled to undergo placement of a new straight or loop arm arteriovenous haemodialysis access graft
- The subject is willing and able to comply with the protocol and associated follow up requirements
- Subjects must have agreed for their data to be entered into the registry as per the local hospital consent procedure
Who cannot join
- Known allergy or sensitivity to ePTFE
- Subject unwilling or unable to comply with the protocol
- Life expectancy of less than 1 year
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Saale-Unstrut Klinikum Naumburg
Naumburg
Thüringen Kliniken Georguis
Saale
Medinos Klinik Sonneberg
Sonneberg
About this study
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.
Read the 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
- Being tested
- ePTFE vascular access grafts
- Keywords
- Vascular access grafts, Haemodialysis
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ePTFE vascular access graftsDevice
Also called RapidaxTM II Vascular access graft
| Study group | Role | What they receive |
|---|---|---|
| haemodialysis vascular access using ePTFE grafts | Not described Receives: Device: ePTFE vascular access grafts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Performance
- Secondary patency at 6 months post implant (Performance)
Measured: 6 months
Safety and Performance
Secondary patency at 12 months post implant (Performance)
Measured: 12 months
Safety and Performance
Freedom from device related Serious Adverse Events at 6 and 12 months (Safety)
Measured: 12 months
Secondary outcomes (4)
Safety and Performance
- Primary patency at 6 months post implant (Performance)
Measured: 6 months
Safety and Performance
Primary patency at 12 months post implant (Performance)
•
Measured: 12 months
Safety and Performance
Assisted primary patency at 6 months (Performance)
•
Measured: 12 months
Safety and Performance
Freedom from device related Serious Adverse Events at 6 and 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startAug 2013
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Vascutek Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bernd Lobenstein, Principal investigator, Saale-Unstrut Klinikum Naumburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977508
- Sponsor's protocol ID
- VAG-001
- Status last verified
- May 2016
- First submitted
- 15 Oct 2013
- Last updated
- 20 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Vascutek Rapidax™ II Post Market Surveillance Registry
- ClinicalTrials.gov ID
- NCT01977508
- Acronym / sponsor ID
- VAG-001
- Conditions
- End Stage Kidney Disease
- Keywords
- Vascular access grafts, Haemodialysis
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Vascutek Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 6 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| haemodialysis vascular access using ePTFE grafts | – | Device: ePTFE vascular access grafts |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Subject is ≥ 18 and ≤ 90 years old
- Subject has a life expectancy of at least 12 months
- Subject is scheduled to undergo placement of a new straight or loop arm arteriovenous haemodialysis access graft
- The subject is willing and able to comply with the protocol and associated follow up requirements
- Subjects must have agreed for their data to be entered into the registry as per the local hospital consent procedure
Key exclusion criteria (3 listed)
- Known allergy or sensitivity to ePTFE
- Subject unwilling or unable to comply with the protocol
- Life expectancy of less than 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ePTFE vascular access graftsAlso: RapidaxTM II Vascular access graft | Device | haemodialysis vascular access using ePTFE grafts |
Primary outcome
Safety and Performance
Time frame: 6 months
* Secondary patency at 6 months post implant (Performance)
Safety and Performance
Time frame: 12 months
Secondary patency at 12 months post implant (Performance)
Safety and Performance
Time frame: 12 months
Freedom from device related Serious Adverse Events at 6 and 12 months (Safety)
4 secondary outcomes
Safety and Performance
Time frame: 6 months
Safety and Performance
Time frame: 12 months
Safety and Performance
Time frame: 12 months
Safety and Performance
Time frame: 12 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernd Lobenstein principal investigator
Saale-Unstrut Klinikum Naumburg
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Kidney Disease, run by Vascutek Ltd. at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Performance (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2016.