Coarctation Of the Aorta Stent Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Change in Difference Between Arm and Leg Systolic Blood Pressure From Baseline to 12 Months
研究概览
简要总结
The purpose of this study is to determine whether Cheatham Platinum bare metal stents are safe and effective in the treatment of native and recurrent aortic coarctation in selected children, adolescents and adults.
详细描述
The goals of this study are to provide information that will support labeling of both the CP bare metal and covered stents to treat native and recurrent aortic coarctation in selected children, adolescents and adults. The investigation will have two phases: Phase One will examine the safety and efficacy of the bare metal stent, and will collect information about the covered stent when used as rescue therapy for aortic injuries occurring during bare metal stent procedures.
The aims of the Phase One study are to assess the use of the CP bare metal stent to:
- provide a reduction equivalent to surgery in arm-leg systolic cuff blood pressure gradient 12 months after dilation and stent implantation, in comparison to the pre-dilation gradient;
- accomplish gradient relief with a shorter number of days in hospital than surgery;
- accomplish gradient relief with a rate of occurrence of serious procedure-related adverse events occurring within 30 days of dilation that is equivalent to surgery; and
- accomplish gradient relief with a rate of occurrence of post-procedural paradoxical hypertension that is lower than surgery.
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
- 8 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Native or recurrent aortic coarctation
- •Weight greater than or equal to 35 kg
- •Noninvasive, arm-leg cuff systolic blood pressure difference or catheter measured systolic coarctation gradient greater than or equal to 20 mmHg
排除标准
- •Age > 60 years
- •Connective tissue disorders, including Marfan syndrome and other genetic syndromes such as Turner syndrome and Noonan syndrome
- •Inflammatory aortitis
- •Bloodstream infection, including endocarditis
- •Pregnancy
- •Aortic aneurysm
- •Prior stent placement
- •Adults lacking capacity to consent
- •Foster children and/or wards of the court
结局指标
主要结局
Change in Difference Between Arm and Leg Systolic Blood Pressure From Baseline to 12 Months
时间窗: 12 months
Noninvasive systolic blood pressures are measured in the arms and legs at baseline and 12 month follow-up. The difference between these measurements are calculated. The difference between systolic arm and leg blood pressures decreased by 30 ± 22 mmHg (n=90)
次要结局
- Systolic Blood Pressure, Difference Between Upper and Lower Extremities(Baseline and 12 months)
- Percentage of Participants With a Systolic Blood Pressure Greater Than the 95th Percentile for Age and Gender 12 Months Post Stent Placement(Baseline and 12 months)
研究者
Richard E. Ringel
MD
Johns Hopkins University