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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: AAA - Abdominal Aortic Aneurysm; TAAA
• Intervention / Treatment: Device: Endovascular Aortic Repair

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.

• Study Type: Observational
• Enrollment (Estimated): 105

Contacts and Locations

• Study Contact: Name: Sonia Sole Sanchez; Phone Number: +34 690 8808 46; Email: Sonia-Sole.Sanchez@artivion.com
• Study Contact Backup: Name: Sara Finocchietti; Phone Number: +33 6 87 67 05 03

Study Locations

• Netherlands
  • Heerlen, Netherlands
    • Zuyderland Medisch Centrum
    • Contact: Lee Bouwman; Phone Number: +31 088 459 7777; Email: l.bouwman@zuyderland.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; BEVAR: minimally invasive procedure used to treat complex aortic aneurysms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success	Technical Success defined as successful delivery and accurate placement of the TUVA/iCover devices in the intended target vessels	Perioperative/Periprocedural
Patency	Bridging stent patency at conclusion of the procedure and at 1 year follow- up visit	1 year
Mortality	Aneurysm related mortality at 1 year follow-up visit.	1 year.
Separation of bridging stent graft	Incidence of separation of bridging stent grafts at 1 year follow-up visit as result of migration.	1 year

Collaborators and Investigators

• Sponsor: JOTEC GmbH

Study record dates

Study Major Dates

• Study Start (Estimated): April 14, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Minimally Invasive Surgical Procedures; Vascular Grafting; Prosthesis Implantation; Blood Vessel Prosthesis Implantation; Endovascular Aneurysm Repair
• Other Study ID Numbers: TUVA BX

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No