NCT04598802已完成不适用
A Physician-initiated, Multicentre, Ambispective, Observational Registry of Patients Undergoing Complex Aortic Procedures With the Use of the Bard Covera Plus (Tempe, Arizona, USA) Covered Self-expandable Stents
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 33
- 主要终点
- technical success
研究概览
简要总结
The purpose of the registry is to evaluate the peri-operative and short-, mid- and long-term outcomes of the Bard Covera Plus (Tempe, Arizona, USA) for the treatment of atherosclerotic aorto-iliac aneurysm in combination with a multibranched endograft
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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 ≥18 years
- •Patients who underwent/will undergo a complex aortic procedure with the use of a Covera Plus covered stent graft as a bridging stent, in the centres involved in this Registry
- •Subject has consented for study participation and signed the approved Informed Consent
排除标准
- •Bleeding diathesis or coagulopathy
- •Patients with active systemic or cutaneous infection or inflammation
- •Patients who are pregnant or lactating
- •Patient younger than 18 years of age
- •Patients who did not receive treatment using a Covera Plus covered stent graft.
结局指标
主要结局
technical success
时间窗: 30 days
freedom from type I or type III endoleak, stenosis/occlusion, dislocation/kinking
Branch instability
时间窗: 30 days
freedom from branch-related complications
Primary clinical success
时间窗: 30 days
freedom from death, type I/III endoleak, graft infection/thrombosis, aneurysm expansion and/or rupture, conversion to open repair, or new treatment-related thoraco-abdominal pathologies
次要结局
未报告次要终点
研究者
Bertoglio Luca
Principal Investigator
IRCCS San Raffaele
研究点 (33)
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