NCT01844037终止2 期
Renal Denervation Using the OneShot Ablation System
Medtronic Endovascular1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2014年7月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Change in office systolic blood pressure (SBP) from baseline to 6 months
研究概览
简要总结
This is a multi-center, prospective registry designed to monitor the outcomes of renal denervation with the OneShot Device in a real-world patient population.
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
- •Patient is an acceptable candidate for renal denervation based upon the Instructions for Use.
- •Patient is ≥ 18 years old.
- •Patient provided written informed consent.
排除标准
- •Patients who are pregnant, nursing, or planning to become pregnant.
- •Patients who have only one functioning kidney.
- •Allergy to contrast or known hypersensitivity to device materials
- •Patients with renal arteries < 4 mm in diameter.
- •Patients whose life expectancy is less than the planned period of study involvement.
结局指标
主要结局
Change in office systolic blood pressure (SBP) from baseline to 6 months
时间窗: 6 months
次要结局
- Change in office diastolic blood pressure (DBP)(6 and 12 months post procedure)
- Change in office SBP(6 and 12 months post procedure)
- Acute procedural safety, defined as freedom from renal artery dissection or perforation requiring intervention.(One Week)
研究者
研究点 (1)
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