Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease

Обзор

The study will assess the safety and effectiveness of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis ("VBX Device" or also referred to as "VBX Stent Graft") in a post approval setting and evaluate the quality of the use in covered endovascular reconstruction of the aortic bifurcation (CERAB) to treat Aortoiliac Occlusive Disease (AIOD).

Подробное описание

A minimum of 158 adult subjects will be enrolled at up to a minimum of 20 sites in the U.S. and Europe. Data will be collected retrospectively and found within existing site files at Baseline, Treatment, Discharge, Pre-12-Month Follow-up, 12-Month Follow-Up, Subsequent Follow-Up Visits.

Вмешательства

• Устройство GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)
  Treatment of Target Lesions with the VBX Device in the aortic and common iliac positions during the CERAB procedure.

Первичные конечные точки

• Primary Effectiveness Endpoint: 1-Year Primary patency (hypothesis testing) [Срок оценки: 1-Year]
• Primary Safety Endpoint: 30-day Morbidity (hypothesis testing) [Срок оценки: 30-Day]

Вторичные конечные точки (8)

• Technical Success [Срок оценки: At index procedure]
• Mortality [Срок оценки: 30-Day]
• Device Integrity [Срок оценки: 1 year]
• Primary assisted patency [Срок оценки: 1 year]
• Secondary patency [Срок оценки: 1 year]
• Freedom from Target Lesion Revascularization [Срок оценки: 1 year]
• Survival [Срок оценки: 1 Year]
• Freedom from Clinically-Driven Target Lesion Revascularization [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Patient treated with covered endovascular reconstruction of the aortic bifurcation (CERAB) procedure for aortoiliac occlusive disease (AIOD).
• Patient was implanted with the VBX Device in the aortic position during a CERAB procedure.
• Patient was treated with the CERAB procedure a minimum of 1 year before enrollment date.
• Age ≥18 years at the time of CERAB procedure.
• Obtain patient informed consent or waiver according to local Institutional Review Board (IRB)/Ethics Committee (EC) -

Критерии исключения

• Patient with prior stenting in the aortic or common iliac artery at the time of CERAB procedure.
• Patient treated with concomitant chimney procedure at time of CERAB procedure (e.g., inferior mesenteric artery, renal artery).
• Participation in another drug or device investigational study at the time of the CERAB procedure date that can confound the study endpoints.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 20 центров

• University of California — Fresno
• University of South Florida — Tampa
• Mayo Clinic Rochester — Rochester
• Cooper University Hospital — Camden
• Rutgers — New Brunswick
• Research Foundation SUNY Buffalo — Buffalo
• Mount Sinai Medical Center — New York
• Research Foundation at SUNY Syracuse — Syracuse
• … и ещё 12 центров

Италия · 2 центра

• Azienda Ospedaliero-Universitaria di Padova — Padova
• Ospedale di Circolo e Fondazione Macchi — Varese

Нидерланды · 2 центра

• Amsterdam UMC Research BV — Amsterdam
• Franciscus — Rotterdam

Испания · 1 центр

• Hospital General Universitario de Alicante — Alicante

Великобритания · 1 центр

• Greater Glasgow Health Board — Glasgow

Идентификаторы

NCT: NCT06872905 · VBX 24-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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