CERAB - Prospective, Non-Randomised Clinical Trial to Investigate the BeGraft Aortic Stent Graft System and the BeGraft Peripheral Stent Graft System Treating Aortic-iliac Occlusive Disease With CERAB
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 109
- 试验地点
- 15
- 主要终点
- Freedom from clinically-driven target lesion revascularization
研究概览
简要总结
This is a prospective, multi-center, investigational study to evaluate safety and performance of the BeGraft Aortic balloon expandable covered Stent Graft System and the BeGraft Peripheral balloon expandable covered stent Graft System (Bentley InnoMed GmbH, Hechingen, Germany) implanted as covered stents in CERAB procedures (Covered Endovascular Reconstruction of Aortic Bifurcation) for extensive aorto-iliac occlusive disease.
The objective of this clinical investigation is to evaluate the safety and performance of the BeGraft Aortic covered stent Graft System & the BeGraft Peripheral covered stent Graft System (Bentley Innomed, Hechingen, Germany) in CERAB configuration (Covered Endovascular Reconstruction of Aortic Bifurcation) for Aorto-iliac Occlusive Disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Freedom from clinically-driven target lesion revascularization
时间窗: at 12 months after procedure
Freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months, defined as freedom from repeat endovascular revascularization to maintain or re-establish patency within the treated lesion.
Incidence of Serious Adverse Device Effects
时间窗: at 12 months after procedure
Incidence of Serious Adverse Device Effects (SADE) and procedure related Serious Adverse Events (SAE) at 12 months follow up.
次要结局
- Patient reported outcomes(at 30 days post-procedure, 6-, 12-, and 24-months)
- Clinical success at every follow up visit(at 30 days post-procedure, 6-, 12-, and 24-months)
- Hemodynamic improvement(at 30 days post-procedure, 6-, 12-, and 24-months)
- Freedom for conversion to open surgical repair(at 30 days post-procedure, 6-, 12-, and 24-months)
- Patency rate of the target vessel(at 30 days post-procedure, 6-, 12-, and 24-months)
- Time to re-vascularization/re-intervention(at 30 days post-procedure, 6-, 12-, and 24-months)
- Technical success rate after procedure(at procedure)
- Safety endpoints(at 30 days post-procedure, 6-, 12-, and 24-months)
研究者
Marc Bosiers, MD
Dr.
FCRE (Foundation for Cardiovascular Research and Education)