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

Catharina Hospital

Status: Completed

Conditions: Vascular Infections

Treatments: Device: No-React Non-valved Conduit

Study type: Observational

Funder types: Other

Identifiers

NCT04031001

NL59973.100.16

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Volunteers: No Healthy Volunteers

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