Data Collection of the TUVA BX and iCover Stent Grafts Implanted During Branched Endovascular Aortic Repair (BEVAR)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJOTEC GmbH
About this trial
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
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Endovascular Aortic Repair
Treatment groups
105 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov