REnAL denervatIon by ultraSound Transcatheter Emission
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Percentage of patients with device- or procedure-related adverse events
研究概览
简要总结
The REALISE trial is a single-arm, open-label, prospective, post market evaluation to be conducted on twenty (20) eligible patients with a twelve month follow-up period.
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
- •Resistant hypertension, as defined in the 2007 ESH-ESC guidelines
- •18 years of age or older
- •Negative pregnancy test for female patients of childbearing potential
- •Willing and able to comply with follow-up requirements
- •Signed informed consent
排除标准
- •Secondary hypertension
- •Main renal arteries length < 20 mm
- •Main renal arteries diameter < 4 mm
- •Renal artery stenosis
- •Iliac/femoral artery stenosis precluding insertion of the catheter
- •Allergy to contrast media
- •Currently participating in the study of an investigational drug or device
- •Hemodynamics abnormality
- •Moderate to severe renal insufficiency
研究组 & 干预措施
Percutaneous renal denervation
干预措施: PARADISE percutaneous renal denervation (Device)
结局指标
主要结局
Percentage of patients with device- or procedure-related adverse events
时间窗: 12 months
Anticipated adverse events include: * Puncture site-related events * Renal artery stenosis, aneurysm, dissection, or perforation * Renal infarction, acute kidney injury, or renal failure * Arterial and venous thromboembolic events (including myocardial infarction, stroke, aortic or peripheral artery disease, etc.)
Percentage of successful interventions
时间窗: Up to 24 hours
A successful intervention is defined by the ability to successfully: 1. Introduce the PRDS catheter 2. Position the PRDS catheter 3. Deliver ultrasound energy 4. Retrieve the PRDS catheter
次要结局
- Change from baseline in anti-hypertensive medication intake(12 months)
- Change from baseline in ambulatory blood pressure(12 months)