NCT02901704Unknown3 期
A Prospective, Multi-centers, Randomized,Controlled, Blinded,Superiority Trial of Renal Denervation Using Iberis MultiElectrode Renal Denervation System for the Treatment of Primary Hypertension.
Shanghai AngioCare Medical0 个研究点目标入组 216 人开始时间: 2016年12月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 216
- 主要终点
- Reduction in average 24-hour ambulatory systolic blood pressue at 3 months follow-up
研究概览
简要总结
The purpose of Iberis-HTN trial is to evaluate the safety and effectiveness of renal denervation in subjects with primary hypertension by using Iberis multielectrode renal denervation system
详细描述
The purpose was to evaluate 3-month outcomes of RDN for the treatment of primary hypertension in Chinese patients.In a prospective, multi-center study, 216 Chinese patients with primary hypertension would be recruited to undergo RDN by Iberis Multielectrode denervation system. The primary effectiveness endpoint wasReduction in average 24-hour ambulatory systolic blood pressue at 3 months follow-up.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 65 years
- •Primary Hypertension
- •Stable medication regimen including 3 antihypertensive medications of different classes, including a diuretic (with no changes for a minimum of 4 weeks prior to screening) and 1) Office SBP ≥150 and ≤180 mmHg, and DBP ≥90 , 2) average 24-hour ambulatory systolic blood pressue and/or DBP ≥135 and ≤170 mmHg
- •Main renal arteries with ≥3 mm diameter or with ≥20 mm treatable length (by visual estimation)
- •Written informed consent
排除标准
- •Clinical Exclusion Criteria:
- •Known secondary hypertension
- •Type 1 diabetes mellitus
- •Has an implantable cardioverter defibrillator (ICD) or pacemaker
- •Myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 6 months of the screening period
- •Has hemodynamically significant valvular heart disease
- •Pregnant, nursing, or planning to be pregnant
- •Any serious medical condition that may adversely affect the safety of the participant or the study
- •Currently enrolled in another investigational drug or device trial
- •2.Angiographic Exclusion Criteria
- •Renal artery stenosis (≥50%) or renal artery aneurysm in either renal artery
- •History of prior renal artery intervention including balloon angioplasty or stenting
- •Multiple renal arteries where the main renal artery is estimated to supply <75% of the kidney
- •Main renal arteries with <3 mm diameter or with <20 mm treatable length (by visual estimation)
- •Renal artery abnormalities
结局指标
主要结局
Reduction in average 24-hour ambulatory systolic blood pressue at 3 months follow-up
时间窗: 3 months
次要结局
- Reduction in average 24-hour ambulatory systolic blood pressue at 6 months(6 months)
- Change in office systolic blood pressure(1 month,3 months,6 months and 12 months)
- Device or procedure related acute adverse events(1 month,3 months,6 months and 12 months)
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