NCT05017935进行中（未招募）不适用
RADIANCE Continued Access Protocol (RADIANCE CAP): A Study of the ReCor Medical Paradise System in Clinical Hypertension
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 80
- 主要终点
- Incidence of Adverse Events
研究概览
简要总结
RADIANCE CAP is a non-randomized study designed to allow for continued access to ultrasound renal denervation therapy via the Paradise System, and to allow for the on-going collection of safety and effectiveness data in subjects with uncontrolled hypertension despite the prescription of antihypertensive medications.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Average office BP ≥140/90 mmHg at screening visit despite taking stables doses of antihypertensive medications for at least 4 weeks prior to consent
- •Documented daytime ABP ≥135/85 mmHg following 4 week run-in/standardization period on antihypertensive medication regimen
排除标准
- •Renal artery anatomy ineligible for treatment
- •Secondary hypertension not including sleep apnea
- •Type I diabetes mellitus or uncontrolled Type II diabetes (defined as plasma HbA1c ≥9.0%)
- •eGFR <40
- •Brachial circumference ≥42 cm
- •Any history of cerebrovascular event or severe cardiovascular event within 3 months prior to consent
- •Documented repeat (>1) hospitalization for hypertensive crisis within 3 months prior to consent
- •Documented confirmed episode(s) of unstable angina within 3 months prior to consent
- •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
结局指标
主要结局
Incidence of Adverse Events
时间窗: From baseline to 60 months
Change in average daytime ambulatory systolic BP
时间窗: From baseline to 2 months post procedure
次要结局
- Change in average daytime/24-hr/night-time ambulatory systolic BP(From Baseline to Months 6 and 12 post procedure)
- Change in average 24-hr/night-time ambulatory systolic BP(From baseline to 2 months post procedure)
- Change in average home systolic/diastolic BP(From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 post procedure)
- Change in average 24-hr/night-time ambulatory diastolic BP(From baseline to Months 2, 6, and 12 post procedure)
- Change in average office systolic/diastolic BP(From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 post procedure)
研究者
研究点 (80)
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