Vascular No-React Graft Against Infection

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04031001

Acronym

VASC-REGAIN

Enrollment

Registered

2019-07-24

Start date

2017-12-22

Completion date

2021-07-13

Last updated

2023-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Infections

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.

Interventions

DEVICENo-React Non-valved Conduit

Operative replacement of infected graft or implantation in infected area.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026