Completed

NCT Number: NCT04031001

Vascular No-React Graft Against Infection

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.

Completed

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Key information

Conditions

Vascular Infections

Sex eligibility

All sexes

Study type

Observational

Primary location

Catharina Ziekenhuis

Eindhoven, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No-React Non-valved Conduit

Device

Operative replacement of infected graft or implantation in infected area.

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Catharina Ziekenhuis Eindhoven

Other

Registry information

Acronym: VASC-REGAIN

Important dates

Study start: 2017
Primary completion: 2021
Study completion: 2021
First posted: Jul 24, 2019
Registry last updated: Dec 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.