A Prospective and Retrospective, Multi-Centre, Post-Market, Non-Interventional Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches

Vascutek Ltd.31 sites in 7 countries2,000 target enrollmentFebruary 17, 2021

ConditionsAneurysm Dissection Aortic Root Aneurysm Aortic Root Dissection Carotid Artery Injuries Aortic Arch Bypass Extremity Graft Occlusive Vascular Disease Aortic Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aneurysm
Sponsor: Vascutek Ltd.
Enrollment: 2000
Locations: 31
Primary Endpoint: Operative Death
Status: Recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this registry is to collect safety and performance data on all commercially available Terumo Aortic knitted and woven grafts, and cardiovascular patches in standard clinical practice.

Data will be collected both retrospectively and prospectively.

Registry

clinicaltrials.gov

Start Date

February 17, 2021

End Date

January 2037

Last Updated

11 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Vascutek Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients must meet all of the following inclusion criteria in order to be eligible for inclusion in the study:
•All Patients:
•Patient meets the minimum age as per local regulations at time of consent
•Patient requires treatment with study device(s) according to the IFU(s)
•Patient is willing and able to comply with all SOC procedures and study visits
•Patient or their legally authorised representative (LAR) has given written informed consent to participate in study, including consent to collect data retrospectively
•For prospective emergency patients, retrospective consent is permissible
•For retrospective patients who are deceased at time of enrollment, local EC regulations relating to consent process should be followed.
•Retrospective Patients only:
•Patient has a minimum of 1 year post-operative follow-up data available, or complete data to death.

Exclusion Criteria

•Any patient who meets any of the following exclusion criteria will be excluded from participation in the study:
•Patient is unable or unwilling to comply with the SOC procedures or follow-up regime
•Patient is contraindicated per the device IFU
•Patient has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre- and post-procedure