Vascular No-React Graft Against Infection

Completed

• Conditions: Vascular Infections

• Registration Number: NCT04031001
• Lead Sponsor: Catharina Ziekenhuis Eindhoven

Brief 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 settings.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-22
• Study First Submitted: 2018-10-05
• Study First Submitted QC: 2019-07-22
• Study First Posted: 2019-07-24
• Primary Completion: 2021-02-06
• Study Completion: 2021-07-13
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-20
• Last Update Posted: 2023-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of graft infection 3 months after implantation	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 Outcome Measures

Name	Time	Method
Percentage of patency 12 months after implantation	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

Trial Locations

Locations (1)

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Netherlands