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Recruiting NCT04545502

PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches

Trial Parameters

Condition Aneurysm
Sponsor Vascutek Ltd.
Study Type OBSERVATIONAL
Phase N/A
Enrollment 2,000
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-02-17
Completion 2026-12
Interventions
Gelsoft Plus Vascular GraftVascular Bypass GraftCardiovascular Patch

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.

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. * Patient implant date is no more than 5 years prior to study start date. Exclusion Criteria: * Any patient w

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