BeFab: An International, Multi-centre Observational Study to Evaluate Safety, Performance, and Clinical Benefit of Bentley Bridging Stent Graft Systems

Bentley InnoMed GmbH0 个研究点目标入组 150 人开始时间: 2026年1月1日最近更新: 2025年12月19日

适应症

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Bentley InnoMed GmbH
入组人数: 150
主要终点: Target vessel instability at 12 months, defined as bridging stent-specific occlusion, stenosis, endoleak Type Ic/IIIc, or re-intervention

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This international, observational multi-centre observational study of the devices BeFlared FEVAR Stent Graft System (BeFlared), BeGraft Stent Graft System (BeGraft), and BeGraft Plus Stent Graft System (BeGraft Plus) will monitor technical success of the implantation, data regarding clinical performance, clinical benefit, as well as potential unknown side effects for the use as bridging stent grafts in combination with fenestrated aortic endovascular grafts.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Adult patients having complex abdominal aortic aneurysms suitable for an endovascular repair with a fenestrated and/or branched aortic endovascular graft in combination with one Bentley bridging stent graft per reno-visceral artery in accordance with the IFU of BeFlared, BeGraft or BeGraft Plus. Use of different products for different target vessels is allowed. Use of stents from other manufacturers for other reno-visceral arteries is allowed.
•Patient is capable and willing to sign the informed consent and agrees to fulfil follow-up requirements
•Patients ≥18 years of age at the time of consent

排除标准

•Patients with contraindications as listed in the IFUs
•Previous stenting of the target vessel
•Extension/relining of Bentley BSGs
•Prior EVAR procedure

结局指标

主要结局

Target vessel instability at 12 months, defined as bridging stent-specific occlusion, stenosis, endoleak Type Ic/IIIc, or re-intervention

时间窗: 12 months post index procedure

次要结局

total time of fluoroscopy(during procedure)
Target vessel instability defined as bridging stent-specific occlusion, stenosis, endoleak Type Ic/IIIc, or re-intervention(1 month, 24 months, 36 months, 48 months, and 60 months post index procedure)
Procedure-related complications(during procedure, at discharge and 1 month and 12 months post index procedure)
Bridging stent-related complications(during procedure, and 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure)
technical success defined as correct positioning and deployment of bridging stent grafts(during procedure)
Primary patency rate defined as uninterrupted patency with no occlusion(1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure)
Secondary patency rate(1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure)
Freedom from secondary procedures(1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure)
Freedom from bridging stent related endoleaks(1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure)
Post-procedure Major adverse event rate(1 month post procedure)
Freedom from aneurysm-related death(1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure)
Freedom from aortic aneurysm maximum diameter increase(1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure)
Device implantation time(during procedure)
Total procedure time(during procedure)
total patient radiation dose(during procedure)
total volume of received contrast medium(during procedure)
Patient blood loss(during the procedure)
duration of ICU stay(1 month post index procedure)
duration of total hospital stay(1 month and 12 months post index procedure)
mortality rate at 30 days(1 month post index procedure)
Quality of life score(1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure)

研究者

发起方

Bentley InnoMed GmbH

申办方类型

Industry

责任方

Sponsor

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