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

NCT07540507 | Not Yet Recruiting

• 1 other identifier: TUVA BX
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

TAAA; AAA - Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (4)

• Technical Success

  Perioperative/Periprocedural

• Patency

  1 year

• Mortality

  1 year.

• Separation of bridging stent graft

  1 year

Study Arms (1)

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).

Device: Endovascular Aortic Repair

Interventions

Endovascular Aortic Repair DEVICE

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

Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a TAAA or AAA that require endovascular aortic repair.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• JOTEC GmbH: lead

Study Sites (1)

Zuyderland Medisch Centrum

Heerlen, Netherlands

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Central Study Contacts

Sonia Sole Sanchez

CONTACT

+34 690 8808 46; Sonia-Sole.Sanchez@artivion.com

Sara Finocchietti

CONTACT

+33 6 87 67 05 03

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 20, 2026
• Study Start: April 14, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

NL (1)