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Clinical Trials in the Netherlands / NCT07540507
Recruiting Observational

Data Collection of the TUVA BX and iCover Stent Grafts Implanted During Branched Endovascular Aortic Repair (BEVAR)

NCT07540507 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Phase
Observational
Started
2026-04-14
Last updated
2026-08-06

Condition(s) studied

TAAAAAA - Abdominal Aortic Aneurysm

Investigational drug(s) / intervention(s)

Endovascular Aortic Repair

Endovascular Aortic Repair: BEVAR: minimally invasive procedure used to treat complex aortic aneurysms.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Zuyderland Medisch Centrum Heerlen Netherlands Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07540507 on ClinicalTrials.gov ↗ ← All trials in the Netherlands