A Randomized Comparison of Strategies for Type B Aortic Dissection - the INvestigation of STEnt-grafts in Aortic Dissection (INSTEAD) Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- All cause mortality
研究概览
简要总结
The objective of INSTEAD is to compare long-term (5 years) outcomes of endograft prosthesis versus medical management in patients with dissection of the thoracic aorta.
详细描述
Patients > 18 years with type B aortic dissection were randomized to either thoracic aortic endoprosthesis (stent-grafting) or antihypertensive management (medical treatment). Only stable patients without spontaneous false lumen thrombosis 14 days after index dissection were considered eligible for study inclusion. Long-term outcome measures included all-cause mortality, aorta-specific mortality and a cluster endpoint (reflecting progression of disease, conversion and additional interventions); the analysis is based on 140 randomized cases followed for at least 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No contraindication the general anesthesia and ventilation
- •Type B aortic dissection that occurred 2-52 weeks prior to randomization
- •Diameter of the targeted aortic segment < 6 cm
- •Subject or legal guardian understand the nature of teh study and agrees to its provisions on a written informed consent form
- •Availability for appropriate follow-up visits during the F/U period of 5 years
- •Capability to follow all study requirements
排除标准
- •Pregnancy
- •Thrombocytopenia
- •Ongoing anticoagulation therapy
- •Renal failure and/or creatinine > 2,4 mg%
- •Complete thrombosis of false lumen
- •Cancer likely to cause death within 1 year
- •Enrollment in another clinical study
- •Unwillingness to cooperate with study procedures or F/U visits
结局指标
主要结局
All cause mortality
时间窗: 5 years post randomization
次要结局
- Aorta-specific mortality(5 years post randomization)
- Progression of disease(5 years)
- Aortic remodeling(5 years)