A Prospective and Retrospective, Multi-Centre, Post-Market, Non-Interventional Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches (PANTHER)
J
Joel Corvera, MD
Primary Investigator
Enrolling By Invitation
18 years and older
All
Phase
N/A
1000 participants needed
1 Location
Brief description of study
The purpose of this registry is to collect safety and performance data on all commerciallyvailable Terumo Aortic knitted and woven grafts, and cardiovascular patches in standard.
Data will be collected both retrospectively and prospectively.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Aneurysm, Dissection, Aortic Root Aneurysm, Aortic Root Dissection, Carotid Artery Injuries, Aortic Arch, Bypass Extremity Graft, Occlusive Vascular Disease, Aortic Diseases
-
Age: 18 Years
-
Gender: All
Inclusion Criteria:
- Patients must meet all of the following inclusion criteria in order to be eligible forusion 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 informedudy, 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 ECgulations relating to consent process should be followed.
Retrospective Patients only:
- Patient has a minimum of 1 year post-operative follow-up data available, or completedata 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 fromhe study:
- Patient is unable or unwilling to comply with the SOC procedures or follow-upgime
- Patient is contraindicated per the device IFU
- Patient has any other medical, social or psychological problems that in thehe investigator preclude them from receiving this treatment and thedures and evaluations pre- and post-procedure
Updated on
01 Aug 2024.
Study ID: PANTHER-001
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