Vascular InfectionsVASC-REGAINNCT04031001
Vascular No-React Graft Against Infection
An observational study of Vascular Infections, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial summary
This study seeks to demonstrate the effectiveness and safety of the Non-valved Conduit for CE marking on the basis of infection. The rationale for infection resistance with the conduit is that BioIntegral Surgical No-React® treated products have a well-documented history of infection resistance in hybrid vascular… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vascular Infections
- What is being tested?
- No-React Non-valved Conduit
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Dec 2017to 13 Jul 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with (a high risk for) infection.
Who may be able to join
- Infected prosthetic graft and/or bifurcation
- High risk of infection at graft implantation
- Mycotic aneurysm
- No alternative available
Who cannot join
- Below-knee procedure
- AV access
Trial locations and contacts
1 site in 1 country.
About this study
This study seeks to demonstrate the effectiveness and safety of the Non-valved Conduit for CE marking on the basis of infection. The rationale for infection resistance with the conduit is that BioIntegral Surgical No-React® treated products have a well-documented history of infection resistance in hybrid vascular settings.
- Conditions
- Vascular Infections
- Being tested
- No-React Non-valved Conduit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No-React Non-valved ConduitDevice
Operative replacement of infected graft or implantation in infected area.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of graft infection 3 months after implantation
Percentage of graft infection 3 months after implantation as assessed with different infection parameters: CRP value, leukocytes, Samson classification of infection, temperature, wound healing, wound infection, purulence
Measured: 3 months after implantation
Secondary outcomes (1)
Percentage of patency 12 months after implantation
Percentage of patency 12 months after implantation as assessed with duplex ultrasound or CT imaging. <50% stenosis are defined as patent
Measured: 12 months after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start22 Dec 2017
- Primary completion6 Feb 2021
- Study completion13 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular InfectionsStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc van Sambeek, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031001
- Sponsor's protocol ID
- NL59973.100.16
- Acronym
- VASC-REGAIN
- Status last verified
- Dec 2023
- First submitted
- 5 Oct 2018
- Last updated
- 21 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular No-React Graft Against Infection
- ClinicalTrials.gov ID
- NCT04031001
- Acronym / sponsor ID
- VASC-REGAIN / NL59973.100.16
- Conditions
- Vascular Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Study start
- 22 Dec 2017 (actual)
- Primary completion
- 6 Feb 2021 (actual)
- Study completion
- 13 Jul 2021 (actual)
- First posted
- 24 Jul 2019 (actual)
- 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.
This study seeks to demonstrate the effectiveness and safety of the Non-valved Conduit for CE marking on the basis of infection. The rationale for infection resistance with the conduit is that BioIntegral Surgical No-React® treated products have a well-documented history of infection resistance in hybrid vascular settings.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with (a high risk for) infection.
Key inclusion criteria (4 listed)
- Infected prosthetic graft and/or bifurcation
- High risk of infection at graft implantation
- Mycotic aneurysm
- No alternative available
Key exclusion criteria (2 listed)
- Below-knee procedure
- AV access
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 |
|---|---|---|
| No-React Non-valved ConduitOperative replacement of infected graft or implantation in infected area. | Device | – |
Primary outcome
Percentage of graft infection 3 months after implantation
Time frame: 3 months after implantation
Percentage of graft infection 3 months after implantation as assessed with different infection parameters: CRP value, leukocytes, Samson classification of infection, temperature, wound healing, wound infection, purulence
1 secondary outcome
Percentage of patency 12 months after implantation
Time frame: 12 months after implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Infections, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of graft infection 3 months after implantation (time frame: 3 months after implantation). 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 21 Dec 2023.