NCT01939392撤回2 期
Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the OneShot Renal Denervation System II
Medtronic Endovascular1 个研究点 分布在 1 个国家开始时间: 2013年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Major adverse event (MAE) rate through 30 days post randomization
研究概览
简要总结
This is a global, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation with the OneShot Renal Denervation System in patients with uncontrolled hypertension.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individual has a systolic blood pressure ≥ 160 mmHg based on an average of three office blood pressure readings.
- •Stable drug regimen including three or more anti-hypertensive medications including a diuretic
排除标准
- •Renal anatomy unsuitable for treatment
- •Presence of hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous
- •Patient has Type I diabetes
- •Has scheduled or planned surgery within the next 6 months
- •Individual is pregnant nursing or plans to be pregnant
结局指标
主要结局
Major adverse event (MAE) rate through 30 days post randomization
时间窗: 30 days
Change in office systolic blood pressure (SBP) from baseline to 6 months post-randomization
时间窗: 6 months
次要结局
- Reduction in SBP by >10 mmHg at 6 months(6 months)
- Changes in office SBP and diastolic blood pressure (DBP) from baseline to follow-up visits(6, 12, 24, and 36 months)
- Acute Procedural Safety(30 days)
- Chronic procedural safety(6 months)
研究者
研究点 (1)
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