NL-OMON55721招募中不适用
The Radiance ll Pivotal Study - A Study of the ReCor Medical Paradise System in Stage ll Hypertension - The *Radiance II* Pivotal Study
ReCor Medical B.V.0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Appropriately signed and dated informed consent
- •Documented history of hypertension
- •Previously or currently prescribed antihypertensive therapy
- •Average seated office BP >= 140/90 mmHg <180/120 mmHg at Screening Visit (V0)
- •while stable for at least 4 weeks on 0-2 anti-hypertensive medications of
- •different classes
- •Able and willing to comply with all study procedures
- •Subjects who meet the following criteria will be considered eligible for
- •randomization:
- •Documented daytime ABP >= 135/85 mmHg and < 170/105 mmHg at Baseline Visit
- •(V1) after 4-week washout/run-in period
- •Suitable renal anatomy compatible with the renal denervation procedure,
- •documented by renal CTA or MRA of good quality performed within one year prior
- •to consent (a CTA or MRA will be obtained in patients without a recent (<=1
- •year) cross-sectional renal imaging) and confirmed by renal angiogram in
- •subjects that continue to procedure
排除标准
- •Renal artery anatomy on either side, ineligible for treatment including:
- •o Main renal artery diameter < 3 mm or > 8 mm
- •o Main renal treatable artery length < 20 mm (may include proximal branching)
- •o A single functioning kidney
- •o Presence of abnormal kidney tumors
- •o Renal artery with aneurysm
- •o Pre-existing renal stent or history of renal artery angioplasty
- •o Pre-existing aortic stent or history of aortic aneurysm
- •o Prior renal denervation procedure
- •o Fibromuscular disease of the renal arteries
- •o Presence of renal artery stenosis of any origin >= 30%
- •o Accessory arteries with diameter >=2mm <3.5 mm or > 8 mm
- •Known, uncorrected causes of secondary hypertension other than sleep apnea
- •Any history of cerebrovascular event (e.g. stroke, transient ischemic event,
- •cerebrovascular accident)
- •Any history of severe cardiovascular event (e.g. myocardial infarction, CABG,
- •acute heart failure requiring hospitalization (NYHA III-IV)
- •Documented confirmed episode(s) of stable or unstable angina
- •Documented repeat (>1) hospitalization for hypertensive crisis within the
- •prior 12 months and/or any hospitalization for hypertensive crisis within three
- •(3) months prior to consent
- •Prescribed to any standard antihypertensive of cardiovascular medication
- •(e.g. beta blockers) for other chronic conditions (e.g. ischemic heart disease)
- •such that discontinuation might pose serious risk to health in the opinion of
- •the Investigator
研究者
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