NCT05965271尚未招募不适用
A Real World Study on Fabulous® Thoracic Aortic Stent System for Stanford B Aortic Dissection
Hangzhou Endonom Medtech Co., Ltd.7 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2023年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 260
- 试验地点
- 7
- 主要终点
- Major adverse events
研究概览
简要总结
A multicenter, retrospective study to evaluate the real-world efficacy of the Fabulous thoracic aortic stent system in the treatment of Stanford Type B aortic dissection.
详细描述
Fabulous Thoracic Aortic Stent System is specially designed for aortic dissection based on PETTICOAT technique.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •≥18 years old, regardless of gender;
- •Subject was diagnosed with Stanford Type B dissection and treated with Fabulous thoracic aortic stent system, including either a covered stent system, a bare stent, or both;
- •With appropriate arterial access and suitable for endovascular aortic repair;
- •Subjects could understand the purpose of the trial, volunteered to participate in the study, signed the informed consent form by themselves or their legal representatives, and were willing to complete the follow-up as required by the protocol.
排除标准
- •Patients have participated in clinical trials of other drugs or medical devices related to target lesion treatment or have participated in clinical trials of other drugs or medical devices and have not reached the primary endpoint;
- •Patients were unable or unwilling to participate in the study;
- •Patients were judged by the investigator to be ineligible for participation in the trial.
结局指标
主要结局
Major adverse events
时间窗: within 30 days after operation
Include all-cause death, aortic rupture, retrograde type A aortic dissection, distal stent graft induced new entry, endoleak, myocardial infarction, respiratory failure, renal failure, intestinal necrosis, permanent paraplegia, ischemic stroke, and severe lower limb ischemia.
次要结局
- Immediate technical success(Immediate during operation)
- All-cause death and dissection related death(3 months,6 months after operation)
- The incidence of reintervention(30 days, 3 months,6 months after operation)
- Change of diameter(30 days, 3 months,6 months after operation)
- Major adverse events(3 months,6 months after operation)
研究者
研究点 (7)
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