PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
About the study
Who can take part
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
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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