TUVA BX and iCover stent grafts used in BEVAR for complex aortic aneurysms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a retrospective, multicenter observational registry evaluating TUVA BX and iCover stent grafts implanted during BEVAR for complex aortic aneurysms. Researchers will collect existing medical records from the index procedure through a 1-year follow-up to assess safety and effectiveness in routine practice. No comparison group is included, and no new treatments or visits are planned beyond standard care. About 105 patients across up to 25 hospitals in Europe, the UK, and Switzerland are expected to participate, with final results anticipated in December 2026.

Why it matters

Who can join: the full rules

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

Where it's running

• Zuyderland Medisch Centrum
  Heerlen, Netherlands Recruiting

Study contacts

• Study coordinator: Sonia Sole Sanchez
• Email: Sonia-Sole.Sanchez@artivion.com
• Phone: +34 690 8808 46

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.