TAAA, AAA - Abdominal Aortic Aneurysm
Conditions
Brief 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.
Detailed description
This study looks at how well a medical devices (called TUVA BX / icover stent grafts) has worked in patients who have already been treated for serious problems in the aorta (the body's main blood vessel). These problems include aneurysms, where the wall of the blood vessel becomes weak and bulges. The device is used during a type of surgery where doctors repair the blood vessel from inside the body using small tubes. These tubes (called stent grafts) help keep the blood vessel open and allow blood to flow normally. The TUVA BX / icover device is used to connect different parts of the repair. No new treatment or extra hospital visits are needed for this study. Instead, researchers will use information that has already been recorded as part of normal care. This includes details from the original treatment up to the patient's one-year check-up. The aim is to confirm that these devices are safe and work well in everyday medical practice. The study will include about 105 patients from up to 25 hospitals across Europe, the UK and Switzerland. It is expected to finish within one year, with final results planned for December 2026.
Interventions
BEVAR: minimally invasive procedure used to treat complex aortic aneurysms.
Sponsors
JOTEC GmbH
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from re-intervention of the targeted vessel due to bridging stent complications at 1 year follow-up visit. | 1 year | Freedom from re-intervention of the targeted vessel due to bridging stent complications at 1 year follow-up visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | Perioperative/Periprocedural | Technical Success defined as successful delivery and accurate placement of the TUVA/iCover devices in the intended target vessels |
| Patency | 1 year | Bridging stent patency at conclusion of the procedure and at 1 year follow- up visit |
| Mortality | 1 year. | Aneurysm related mortality at 1 year follow-up visit. |
| Separation of bridging stent graft | 1 year | Incidence of separation of bridging stent grafts at 1 year follow-up visit as result of migration. |
Countries
Netherlands
Contacts
CONTACTSonia Sole Sanchez
CONTACTSara Finocchietti
Outcome results
None listed