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NCT07540507
Data Collection of the TUVA BX and iCover Stent Grafts Implanted During Branched Endovascular Aortic Repair (BEVAR)
Conditions: TAAA, AAA - Abdominal Aortic Aneurysm
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 105
Sponsor: JOTEC GmbH
Location: Zuyderland Medisch Centrum Heerlen
Summary
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07540507). StuddyBuddy aggregates publicly available trial information.