Vascular No-React Graft Against Infection

Vascular Infections Clinical Trial

— VASC-REGAIN  

Official title:

Vascular No-React Graft Against Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04031001
• Other study ID #: NL59973.100.16
• Status: Completed
• Start date: December 22, 2017
• Est. completion date: July 13, 2021

Study information

• Verified date: December 2023
• Source: Catharina Ziekenhuis Eindhoven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 settings.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 13, 2021
• Est. primary completion date: February 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Vascular Infections

Intervention

Device:
• No-React Non-valved Conduit
Operative replacement of infected graft or implantation in infected area.

Locations

Country	Name	City	State
Netherlands	Catharina Ziekenhuis	Eindhoven

Sponsors (1)

Lead Sponsor	Collaborator
Catharina Ziekenhuis Eindhoven

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months after implantation
Secondary	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	12 months after implantation