Vascular No-React Graft Against Infection (VASC-REGAIN)

December 20, 2023 updated by: Marc van Sambeek, Catharina Ziekenhuis Eindhoven
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Eindhoven, Netherlands
        • Catharina Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with (a high risk for) infection.

Description

Inclusion Criteria:

  • Infected prosthetic graft and/or bifurcation
  • High risk of infection at graft implantation
  • Mycotic aneurysm
  • No alternative available

Exclusion Criteria:

  • Below-knee procedure
  • AV access

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months after implantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patency 12 months after implantation
Time Frame: 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
12 months after implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catharina Ziekenhuis Eindhoven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2017

Primary Completion (Actual)

February 6, 2021

Study Completion (Actual)

July 13, 2021

Study Registration Dates

First Submitted

October 5, 2018

First Submitted That Met QC Criteria

July 22, 2019

First Posted (Actual)

July 24, 2019

Study Record Updates

Last Update Posted (Actual)

December 21, 2023

Last Update Submitted That Met QC Criteria

December 20, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL59973.100.16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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