NCT07540507 Data Collection of the TUVA BX and iCover Stent Grafts Implanted During Branched Endovascular Aortic Repair (BEVAR)
| NCT ID | NCT07540507 |
| Status | Recruiting |
| Phase | — |
| Sponsor | JOTEC GmbH |
| Condition | TAAA |
| Study Type | OBSERVATIONAL |
| Enrollment | 105 participants |
| Start Date | 2026-04-14 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 105 participants in total. It began in 2026-04-14 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07540507 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying TAAA. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07540507 currently recruiting?
Yes, NCT07540507 is actively recruiting participants. Contact the research team at Sonia-Sole.Sanchez@artivion.com for enrollment information.
Where is the NCT07540507 trial being conducted?
This trial is being conducted at Heerlen, Netherlands.
Who is sponsoring the NCT07540507 clinical trial?
NCT07540507 is sponsored by JOTEC GmbH. The trial plans to enroll 105 participants.