TrAnsCatHeter Intravascular Ultrasound Energy deliVery for rEnal Denervation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 16
- 主要终点
- Change from baseline in systolic blood pressure
研究概览
简要总结
The ACHIEVE study is a single-arm, open-label, prospective, post-market follow-up study to include up to one hundred (100) eligible patients as defined within the clinical investigational plan, with a twelve month follow-up period. The ACHIEVE study was originally designed in accordance with the 2007 ESH ESC guidelines for resistant hypertension.
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
- •Untreated allergy to contrast media
- •Currently participating in the study of an investigational drug or device
- •Moderate to severe renal insufficiency
结局指标
主要结局
Change from baseline in systolic blood pressure
时间窗: 12 months
Change from baseline in systolic blood pressure
Percentage of patients with device- or procedure-related adverse events
时间窗: 12 months
Anticipated adverse events include: * Access site and access-related vascular injury * Renal artery complications, including: stenosis, aneurysm, dissection, and perforation * Renal complications, including: renal infarction, acute kidney injury, and renal failure * Arterial and venous thromboembolic events, including: myocardial infarction, stroke or transient ischemic attack, pulmonary embolism, and deep vein thrombosis * Systemic effects, including: allergic reaction and infection
次要结局
- Change from baseline in anti-hypertensive medication intake(12 months)
- Change from baseline in diastolic blood pressure(12 months)
- Changes from baseline in pulse pressure and nocturnal dipping(12 months)