NCT01568320已完成不适用
Use of the Zenith® Dissection Endovascular System in the Treatment of Patients With Acute, Complicated Type B Aortic Dissection
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 24
- 主要终点
- Survival Rate at 30 Days
研究概览
简要总结
The Zenith® Dissection Clinical Trial is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of acute, complicate Type B aortic dissection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Exclusion Criteria:
- •Age < 18 years;
- •Other medical condition (e.g., cancer, congestive heart failure) that may cause the patient to be non-compliant with the Clinical Investigation Plan, confound the results, or is associated with limited life expectancy (i.e., less than 2 years);
- •Pregnant, breast-feeding, or planning on becoming pregnant within 60 months;
- •Unwilling or unable to comply with the follow-up schedule;
- •Inability or refusal to give informed consent;
- •Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.);
- •Additional medical restrictions as specified in the Clinical Investigation Plan; or
- •Additional anatomical restrictions as specified in the Clinical Investigation Plan.
排除标准
- •Age < 18 years;
- •Other medical condition (e.g., cancer, congestive heart failure) that may cause the patient to be non-compliant with the Clinical Investigation Plan, confound the results, or is associated with limited life expectancy (i.e., less than 2 years);
- •Pregnant, breast-feeding, or planning on becoming pregnant within 60 months;
- •Unwilling or unable to comply with the follow-up schedule;
- •Inability or refusal to give informed consent;
- •Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.);
- •Additional medical restrictions as specified in the Clinical Investigation Plan; or
- •Additional anatomical restrictions as specified in the Clinical Investigation Plan.
研究组 & 干预措施
Endovascular
Experimental
Endovascular Treatment (Zenith)
干预措施: Endovascular Treatment (Zenith) (Device)
结局指标
主要结局
Survival Rate at 30 Days
时间窗: 30 days
Primary effectiveness endpoint is freedom from all cause mortality at 30 days
Number of Participants With Freedom From Major Adverse Events
时间窗: 30 days
Primary safety : Major adverse events include: myocardial infarction, chronic renal insufficiency/chronic renal failure requiring dialysis, bowel ischemia, stroke, paraplegia or paraparesis, and prolonged ventilator support
次要结局
未报告次要终点
研究者
研究点 (24)
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