GREAT Registry (Follow-up)
https://clinicaltrials.gov/ct2/show/NCT01658787
Last updated
https://clinicaltrials.gov/ct2/show/NCT01658787
Last updated
GORE aortic products for abdominal aortic aneurysms.
Dr. Mendes
Sponsor: Gore
CRO: Fortrea
Contact: Vance, Amanda
EDC: iMedidata
Images: NA
eTMF: NA
This is a registry with contiguous follow-up windows. This means that there are no "out-of-window visits", any visit they come in for can be matched into one of the windows.
this is up to date as of 05 June 2023.
Back up coordinator: Soumya Sidana
This is a rather disorganised study. The sponsor/protocol has very vague definitions on what is required or expected. Monitoring has been loose (I don't think they ever monitored).
My suggestion is - do your best with it, try to keep an eye out for patients who come in for follow-ups, report AEs as you get notified about them, etc. Do NOT be a perfectionist with this study.
Rebecca is aware that this study is disorganised and I think she is going to try talk with the sponsors to see if we could end early. All this is to say - speak with her if you have any concerns about this study, she knows it is a challenging one to manage.