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Data Collection of the TUVA BX and iCover Stent Grafts Implanted During Branched Endovascular Aortic Repair (BEVAR)

Recruitingn/aAges 18 Years - anyAllJOTEC GmbH
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ 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
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What it tests

  • Endovascular Aortic Repair
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Where

1 site
Zuyderland Medisch Centrum
Heerlen, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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