Data Collection of the TUVA BX and iCover Stent Grafts Implanted During Branched Endovascular Aortic Repair (BEVAR)
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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 population
Patients with a TAAA or AAA that require endovascular aortic repair.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Endovascular Aortic Repair
DeviceBEVAR: minimally invasive procedure used to treat complex aortic aneurysms.
Treatment groups
105 Participants
are divided into 1 treatment groupGroup A: Device1 intervention
Trial outcomes
Primary outcomes
1
Freedom from re-intervention of the targeted vessel due to bridging stent complications at 1 year follow-up visit.
Freedom from re-intervention of the targeted vessel due to bridging stent complications at 1 year follow-up visit.
Time frame
1 yearSecondary outcomes
1
Technical Success
Technical Success defined as successful delivery and accurate placement of the TUVA/iCover devices in the intended target vessels
Time frame
Perioperative/Periprocedural2
Patency
Bridging stent patency at conclusion of the procedure and at 1 year follow- up visit
Time frame
1 year3
Mortality
Aneurysm related mortality at 1 year follow-up visit.
Time frame
1 year.4
Separation of bridging stent graft
Incidence of separation of bridging stent grafts at 1 year follow-up visit as result of migration.
Time frame
1 year Source ClinicalTrials.gov