An observational study in TAAA and AAA - Abdominal Aortic Aneurysm, sponsored by JOTEC GmbH. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by JOTEC GmbH · Observational
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.
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.
467 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 99 are open to participants now.
This study's planned enrollment of 105 is below the median of 165 across 217 observational studies indexed under Aortic Aneurysm, Abdominal.
Browse Aortic Aneurysm, Abdominal studies →JOTEC GmbH is the lead sponsor of 20 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with a TAAA or AAA that require endovascular aortic repair.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients implanted with the TUVA BX or iCover stent grafts implanted as bridging stent graft in BEVAR (branched endovascular aortic repair) for thoracoabdominal aortic aneurysms (TAAA) and complex abdominal aortic aneurysms (AAA).
Device: Endovascular Aortic Repair
BEVAR: minimally invasive procedure used to treat complex aortic aneurysms.
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 year
Technical Success
Technical Success defined as successful delivery and accurate placement of the TUVA/iCover devices in the intended target vessels
Time frame: Perioperative/Periprocedural
Patency
Bridging stent patency at conclusion of the procedure and at 1 year follow- up visit
Time frame: 1 year
Mortality
Aneurysm related mortality at 1 year follow-up visit.
Time frame: 1 year.
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
Started Apr 2026 (actual). Primary completion is estimated for Sep 2026, 5 months after the start.
How these figures are worked out, and which studies are left out of them.
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