Data Collection of the TUVA BX and iCover Stent Grafts Implanted During Branched Endovascular Aortic Repair (BEVAR)
Recruiting now
Conditions studied: TAAA, AAA - Abdominal Aortic Aneurysm
In brief
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.
Key facts
- Study ID
- NCT07540507
- Run by
- JOTEC GmbH
- People needed
- 105
- Starts
- 2026-04-14
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-08-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Zuyderland Medisch Centrum — Heerlen, Netherlands (enrolling)
Full record on ClinicalTrials.gov
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