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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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 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

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

NCT04545502

Vascutek Ltd.

15 April 2024

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FAQs

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