The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 224
- 试验地点
- 50
- 主要终点
- Change in Average Daytime Ambulatory Systolic BP
研究概览
简要总结
The objective of the RADIANCE II Pivotal study is to demonstrate the effectiveness and safety of the Paradise System in subjects with Stage 2 hypertension on 0-2 medications at the time of consent. Prior to randomization, subjects will be hypertensive in the absence of hypertension medication.
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
- Double (Participant, Outcomes Assessor)
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
- •Previously or currently prescribed antihypertensive therapy
- •Average office BP ≥ 140/90 mmHg <180/120 mmHg while stable for at least 4 weeks on 0-2 classes of antihypertensive medication
- •Documented daytime ABP ≥ 135/85 mmHg and < 170/105 mmHg after 4-week washout/run-in period
排除标准
- •Lacks appropriate renal artery anatomy for treatment
- •Known, uncorrected causes of secondary hypertension other than sleep apnea
- •Type I diabetes mellitus or uncontrolled Type II diabetes
- •eGFR of <40
- •Brachial circumference ≥ 42 cm
- •Any history of cerebrovascular event or severe cardiovascular event, or history of stable or unstable angina within 12 months prior to consent
- •Repeat (>1) hospitalization for hypertensive crisis within 12 months prior to screening period, or any hospitalization for hypertensive crisis within 3 months prior to screening period
- •Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
- •Primary pulmonary hypertension
- •Night shift workers
- •Pregnant, nursing or planning to become pregnant
研究组 & 干预措施
Renal Denervation
Renal Angiogram and Renal Denervation (Paradise Renal Denervation System)
干预措施: Paradise Renal Denervation System (Device)
Sham Control
Renal Angiogram
干预措施: Renal Angiogram (Procedure)
结局指标
主要结局
Change in Average Daytime Ambulatory Systolic BP
时间窗: From baseline to 2 months post-procedure
The primary efficacy outcome is the mean change in daytime ambulatory systolic blood pressure at 2 months
Percentage of Participants With Major Adverse Events (MAE)
时间窗: From baseline to 30 days post-procedure
The primary safety composite outcome of major adverse events included death, kidney failure, and major embolic, vascular, cardiovascular, cerebrovascular, and hypertensive events at 30 days.
Change in average daytime ambulatory systolic BP
时间窗: From baseline to 2 months post-procedure
Incidence of Major Adverse Events (MAE)
时间窗: From baseline to 30 days post-procedure
次要结局
- Change in Average 24-hr Ambulatory Systolic BP(From baseline to 2 months post-procedure)
- Change in Average Office Systolic BP(From baseline to 2 months post-procedure)
- Change in Average Home Systolic BP(From baseline to 2 months post-procedure)
- Change in Average Daytime Ambulatory Diastolic BP(From baseline to 2 months post-procedure)
- Change in Average 24-hr Ambulatory Diastolic BP(From baseline to 2 months post-procedure)
- Change in Average Office Diastolic BP(From baseline to 2 months post-procedure)
- Change in Average Home Diastolic BP(From baseline to 2 months post-procedure)
- Change in average 24-hr ambulatory diastolic BP(From baseline to 2 months post-procedure)
- Change in average office systolic BP(From baseline to 2 months post-procedure)
- Change in average daytime ambulatory diastolic BP(From baseline to 2 months post-procedure)
- Change in average office diastolic BP(From baseline to 2 months post-procedure)
- Change in average 24-hr ambulatory systolic BP(From baseline to 2 months post-procedure)
- Change in average home systolic BP(From baseline to 2 months post-procedure)
- Change in average home diastolic BP(From baseline to 2 months post-procedure)