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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Freedom from re-intervention of the targeted vessel due to bridging stent complications at 1 year follow-up visit. [Срок оценки: 1 year]

Вторичные конечные точки (4)

• Technical Success [Срок оценки: Perioperative/Periprocedural]
• Patency [Срок оценки: 1 year]
• Mortality [Срок оценки: 1 year.]
• Separation of bridging stent graft [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Нидерланды · 1 центр

• Zuyderland Medisch Centrum — Heerlen

Идентификаторы

NCT: NCT07540507 · TUVA BX

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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