Condition: TAAA · AAA - Abdominal Aortic Aneurysm · Sponsor: JOTEC GmbH
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The study aims to check whether the TUVA BX and iCover stent grafts are safe and work well when used during a specific type of minimally invasive surgery (BEVAR) to treat complex aortic aneurysms. It is a retrospective study and it is conducted at multiple hospitals and does not include a comparison group. Researchers will collect and review patient data from medical records, starting from the original procedure and continuing through the 1-year follow-up visit.
This description comes directly from the study's public registry record.
Sonia Sole Sanchez · +34 690 8808 46 · Sonia-Sole.Sanchez@artivion.com
Sara Finocchietti · +33 6 87 67 05 03
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
Inclusion Criteria: * Age ≥ 18 years at the time of index procedure * Patients must have a completed treatment of TAAA or complex AAA treated with E-nside TAAA Multibranch Stent Graft System (E-nside) or E-xtra Design MultiBranch Stent Graft System (EDM) and with at least one target vessel (CT, SMA, LRA, RRA) bridged with any combination of TUVA BX or iCover. * The index procedure was performed after January 2020. * The patient is not deceased and has already completed or expects to complete the 1 year follow-up visit prior to July 2026; or the patient died. * Patients have been consented according to the local regulation. Exclusion Criteria: * Patient treated for ruptured aneurysm or who were otherwise hemodynamically unstable before the procedure. * Patients enrolled in an investigational study that could confound registry endpoints at index procedure. * Patients who developed a new onset of aortic disease (in any segment) since index procedure, potentially having an impact on the performance of the TAAA or TUVA BX /iCover, devices at the discretion of the investigator
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Zuyderland Medisch Centrum | Heerlen, Netherlands | Recruiting |
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