Vascular No-React Graft Against Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-22

Study Completion Date

2021-07-13

Brief Summary

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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

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Conditions

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Vascular Infections

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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No-React Non-valved Conduit

Operative replacement of infected graft or implantation in infected area.

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Marc van Sambeek

prof. dr. M.R.H.M. van Sambeek

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Catharina Ziekenhuis

Eindhoven, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL59973.100.16

Identifier Type: -

Identifier Source: org_study_id