NCT02094300已完成不适用
Zenith® Dissection Endovascular System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 10
- 主要终点
- Number of Patients With Major Complications
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 patients with 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
- •Branch vessel obstruction/compromise
- •Peri-aortic effusion/hematoma
- •Resistant hypertension
- •Persistent pain/symptoms
- •Transaortic growth >5 mm within 3 months
- •Transaortic diameter >40 mm.
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 protocol, 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 24 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.
结局指标
主要结局
Number of Patients With Major Complications
时间窗: 30 days
Major complication is defined as: Retrograde dissection, cardiac events requiring surgical management, prolonged ventilation requiring tracheotomy, renal failure requiring dialysis (where not previously needed), aortic fistula, mesenteric ischemia requiring surgical management, paralysis or paraparesis unresolved after 30 days of therapy, pulmonary embolism, stroke, and multi-system organ failure, unless related to presenting condition.
次要结局
未报告次要终点
研究者
研究点 (10)
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