PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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 Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Aneurysm,Dissection,Aortic Root Aneurysm,Aortic Root Dissection,Carotid Artery Injuries,Aortic Arch,Bypass Extremity Graft,Occlusive Vascular Disease,Aortic Diseases
Age
18+
Participants Needed
2000
Est. Completion Date
Jan 31, 2037
Treatment Type
OBSERVATIONAL
Sponsor
Vascutek Ltd.
ClinicalTrials.gov NCT Identifier
NCT04545502
Study Number
PANTHER-001
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