TAAANCT07540507
Data Collection of the TUVA BX and iCover Stent Grafts Implanted During Branched Endovascular Aortic Repair (BEVAR)
An observational study of TAAA and AAA - Abdominal Aortic Aneurysm, run by JOTEC GmbH at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TAAA, AAA - Abdominal Aortic Aneurysm
- What is being tested?
- Endovascular Aortic Repair
- Type of treatment
- Medical device
- How many people
- 105 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Apr 2026to 31 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a TAAA or AAA that require endovascular aortic repair.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sara Finocchietti contact
Netherlands1 site, 1 recruiting
- Recruiting
Zuyderland Medisch Centrum
Heerlen
Lee Bouwman, +31 088 459 7777, l.bouwman@zuyderland.nl
About this study
Official title: Retrospective Data Collection of the TUVA BX and iCover Stent Grafts Implanted During Branched Endovascular Aortic Repair (BEVAR)
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.
Read the 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.
- Conditions
- TAAA, AAA - Abdominal Aortic Aneurysm
- Being tested
- Endovascular Aortic Repair
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular Aortic RepairDevice
BEVAR: minimally invasive procedure used to treat complex aortic aneurysms.
| Study group | Role | What they receive |
|---|---|---|
| Device | 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). Receives: Device: Endovascular Aortic Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (4)
Technical Success
Technical Success defined as successful delivery and accurate placement of the TUVA/iCover devices in the intended target vessels
Measured: Perioperative/Periprocedural
Patency
Bridging stent patency at conclusion of the procedure and at 1 year follow- up visit
Measured: 1 year
Mortality
Aneurysm related mortality at 1 year follow-up visit.
Measured: 1 year.
Separation of bridging stent graft
Incidence of separation of bridging stent grafts at 1 year follow-up visit as result of migration.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start14 Apr 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TAAAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JOTEC GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540507
- Sponsor's protocol ID
- TUVA BX
- Status last verified
- Aug 2026
- First submitted
- 7 Apr 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No