Меню
Идёт набор NCT07279649

GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Post-Market Clinical Follow-Up (PMCF) Observational Registry (RE-PROVE)

Наблюдательное Aorto-iliac Occlusive Disease (AIOD) Visceral Artery Occlusive Disease (VAOD) Isolated Artery Aneurysms (IAA) Trauma or Iatrogenic Vessel Injury

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB).
Кому может быть актуально
Состояния в реестре: Aorto-iliac Occlusive Disease (AIOD), Visceral Artery Occlusive Disease (VAOD), Isolated Artery Aneurysms (IAA), Trauma or Iatrogenic Vessel Injury. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Collect real-world post-market clinical follow-up data on subjects treated with the Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB)

Подробное описание

This is a prospective, multicenter, observational registry to collect real world data of the Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB) device.

The registry population will include subjects presenting with clinical conditions consistent with the BXB device indications for use and in accordance with standard of care. The following subject cohorts will be included in the registry:

* De novo or restenotic lesions in the iliac arteries including lesions at the aortic bifurcation \[Aortoiliac occlusive disease (AIOD)\], * De novo or restenotic lesions in the visceral arteries \[Visceral artery occlusive disease (VAOD)\], * Isolated visceral, iliac, and subclavian artery aneurysms \[IAA\], or * Traumatic or iatrogenic vessel injuries in arteries that are located in the chest cavity, abdominal cavity, or pelvis (except for aorta, coronary, innominate, carotid, vertebral, and pulmonary arteries) \[Arterial Injury (AI)\].

To satisfy a key objective of the PMCF plan, clinical data will be collected in other indications outside of those listed above (Other cohort).

Approximately 24 clinical investigative sites in Europe, will participate in this registry. 240 subjects will be implanted in this study with a limit of 48 subjects treated / implanted per site. If a site reaches 48 subjects, enrolment will be closed for that site. All subjects will be followed through 12 months (1 year) post-procedure per standard of care. Quality of Life questionnaires will also be collected for all follow-up visits.

Вмешательства

  • Устройство Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB)
    This registry will collect data for eligible commercially available BXB device(s). The BXB device(s) will not be provided to the sites by the Sponsor. The BXB device implant procedure will be performed according to standard practice of the enrolling institution.

Первичные конечные точки

  • Freedom from device-related Serious Adverse Event (SAE) for patients treated with BXB device [Срок оценки: within 30 days after the treatment]
  • Procedural Success for patients treated with BXB device [Срок оценки: at the time of implant]
Вторичные конечные точки (8)
  • Primary patency for patients treated in Aortoiliac Occlusive Disease (AIOD) through 1 year follow-up [Срок оценки: from the time of the index procedure up to 365 days (±window, between days 335 and 455)]
  • Freedom from major amputation of the BXB device treated limb for patients treated in AIOD [Срок оценки: from the time of the index procedure up to 365 days (±window, between days 335 and 455)]
  • Primary patency for patients treated in Visceral Occlusive Disease (VAOD) [Срок оценки: from the time of the index procedure up to 365 days (±window, between days 335 and 455)]
  • Survival for patients treated in VAOD [Срок оценки: from the time of the index procedure up to 365 days (±window, between days 335 and 455)]
  • Freedom from reintervention through 1 year follow-up for patients treated in Isolated Artery Aneurysm (Subclavian, Visceral, Iliac) [Срок оценки: from the time of the index procedure up to 365 days (±window, between days 335 and 455)]
  • 30 Day Mortality for patients treated in IAA [Срок оценки: from the time of the index procedure through 30 days]
  • Treated vessel primary patency through 1 year follow-up for patients treated Trauma or Iatrogenic Vessel Injury [Срок оценки: from the time of the index procedure up to 365 days (±window, between days 335 and 455)]
  • Device-related adverse events (i.e. thrombosis) for patients treated in Trauma or or Iatrogenic Vessel Injury [Срок оценки: from the time of the index procedure up to 365 days (±window, between days 335 and 455)]

Критерии участия

Критерии включения

  • Age ≥18 years
  • Informed Consent Form (ICF) is signed by subject
  • Suitable for endovascular treatment with the Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (BXB) device
  • Willingness of the subject to adhere to institutional standard of care follow-up requirements

Критерии исключения

  • Previous or concurrent enrollment into this registry (e.g., previous enrollment into another treatment cohort or subject requires enrollment into more than one cohort) (Note: Only the first treatment will be enrolled if concurrent procedures are performed that would require enrollment into more than one cohort).
  • Participation in concurrent research study or registry which may confound registry results, unless approved by Gore.
  • Known hypersensitivity to heparin, including a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.
  • Life expectancy <12 months due to comorbidities or unlikely to be available for standard of care follow-up visits as defined by sites.
  • Known intolerance to anticoagulant and / or antiplatelet therapy at the time of the index procedure
  • Subject has a known allergy to contrast or the Reduced Profile VBX Stent (BXB) device components at the time of index procedure that cannot be adequately mitigated.
  • Pregnant or breast-feeding subject at time of informed consent signature.
  • Subject has other medical conditions which, as determined by the investigator, may confound the data interpretation (e.g., sepsis, thrombophilic diseases, connective tissue disorders).

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Германия · 1 центр
  • TUM Klinikum — Munich

Идентификаторы

NCT: NCT07279649 · VBX 22-08

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗