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

RECRUITING
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18 years and over
This study is NOT accepting healthy volunteers
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

DEVICE: Gelsoft Plus Vascular Graft, DEVICE: Vascular Bypass Graft, DEVICE: Cardiovascular Patch, DEVICE: Gelweave Vascular Graft, DEVICE: Gelweave Valsalva Vascular Graft

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

Vascular Surgery

Clinical Study Manager - r.smith1@terumoaortic.com
NCT04545502
See this study on ClinicalTrials.gov

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