Multicenter Study Collecting Post-market Clinical Data on the Dominus® Stent-Graft for Treating Thoracic Aortic Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Early occurrence of adverse events (Safety Outcome)
研究概览
简要总结
Real-world clinical trial evidence post-market, evaluating the safety and efficacy of the Dominus® StentGraft Endoprosthesis in treating thoracic aortic diseases, following the Instructions for Use
详细描述
The multicenter study aims to collect post-market clinical data on the Dominus® Stent-Graft in the treatment of thoracic aortic diseases. With the goal of assessing safety and efficacy, the prospective follow-up study will include 100 patients undergoing Endovascular Treatment of Thoracic Aortic Diseases, following the product's Instructions for Use
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
- •18 years of age or older;
- •Patients treated with the Dominus® Stent-Graft Endoprosthesis in accordance with its Instructions for Use;
- •Patient available for appropriate follow-up times for the study duration;
- •Informed patient about the nature of the study, agreeing to its provisions, and signing the informed consent.
排除标准
- •Patient currently participating in another clinical study of drug or medical device;
- •Life expectancy less than 12 months.
结局指标
主要结局
Early occurrence of adverse events (Safety Outcome)
时间窗: 1 month post index procedure
Early rate Major Adverse Events (MAEs), including all-cause mortality, acute myocardial infarction (AMI), stroke, permanent paraplegia, and recent-onset renal failure (requiring dialysis).
次要结局
- Device Success(Intraoperative)
- Absence of endoprosthesis fracture(1 month and 1 year)
- Endoleak(At the end of surgery/procedure, 1 month, 6 month, 1, 2, 3, 4 and 5 years)
- Reintervention-free(At the end of surgery/procedure, 1 month, 6 month, 1, 2, 3, 4 and 5 years)
- Adverse Events(At the end of surgery/procedure, 1 month, 6 month, 1, 2, 3, 4 and 5 years)