NCT02690909Unknown不适用
A Prospective, Post-marketing, Single-arm, Open Label, Multi-center Clinical Study to Evaluate the Safety and Efficacy of the ReDy™ Renal Denervation System in the Treatment of Patients With Uncontrolled Hypertension
Renal Dynamics GmbH10 个研究点 分布在 8 个国家目标入组 55 人开始时间: 2016年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 55
- 试验地点
- 10
- 主要终点
- Device-related adverse events at 1-month follow-up post treatment
研究概览
简要总结
The ReDy™ System (Renal Dynamics) is a renal denervation device incorporating a variety of ablation features and technical improvements over previously designed systems into a single product. It is intended to treat uncontrolled (drug-resistant) hypertension by RF ablation of the sympathetic nerve network surrounding the renal arteries.
This study will be carried out to validate the safety and the efficacy of the ReDy™ Renal Denervation device and to demonstrate that it performs according to its intended use, i.e. the treatment of patients with uncontrolled 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has established hypertension (diagnosed ≥12 months prior to screening) and is on a guideline based stable drug regimen (≥ 4 weeks), consisting of ≥3 anti-hypertensive medications of different classes including a diuretic;
- •Office systolic blood pressure >150 mmHg;
- •Patient has (under directly observed therapy) average daytime systolic blood pressure values > 140 mmHg by 24h ambulatory blood pressure monitoring;
- •Patient is ≥ 18 and ≤ 75 years of age at time of consent;
- •Patient must be able and willing to comply with the required follow-up schedule;
- •Patient must be able and willing to provide written informed consent;
排除标准
- •Patient has known significant reno-vascular abnormalities such as renal artery stenosis > 30%;
- •Patient has "Isolated Systolic Hypertension" with a diastolic blood pressure < 90 mmHg;
- •Evidence or history of secondary hypertension, other than sleep apnea syndrome;
- •Patient has a history of prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent graft placement;
- •Patient has significant valvular heart disease;
- •Patient has known coagulation abnormalities;
- •Patient life expectancy is < 12 months, as estimated by the study Investigator;
- •Patient is participating in another clinical study, which is before its primary endpoint and/or has the potential to impact his/her hypertension management (pharmaceutical / device);
- •Patient is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods;
- •Patient has active systemic infection;
- •Patient has small <4.0 mm in diameter, large >6.5 mm in diameter or short <20.0 mm in length, multiple main, or highly tortuous renal arteries;
- •Patient has impaired renal function with an estimated GFR <45 mL/min per 1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula;
- •Patient had a renal transplant or is awaiting a renal transplant;
- •Patient has a known intolerance for x-ray contrast agent that cannot be adequately controlled with pre-medication;
- •Any medical condition as estimated by the Study Investigator that may harm patient or jeopardize study participation, the interpretation of study results or may impede the ability to obtain informed consent (e.g., mental condition);
研究组 & 干预措施
Redy™ Renal Denervation System
Experimental
Renal Denervation System
干预措施: Redy™ Renal Denervation System (Device)
结局指标
主要结局
Device-related adverse events at 1-month follow-up post treatment
时间窗: 1-month post treatment
Incidence of device-related Adverse Events at 1-month follow-up post treatment
次要结局
- Peri-procedural Adverse Events at 1-month follow-up post treatment(1-month post treatment)
- Device-related Adverse Events at 3 and 6 months follow-up post treatment(3 and 6 months post treatment)
- Reduction of average systolic daytime blood pressure assessed by 24h ABPM at 3-months(3 months post treatment)
- Reduction of office systolic blood pressure at 1, 3 and 6 months post treatment(1, 3 and 6 months post treatment)
- Reduction of office diastolic blood pressure at 1, 3 and 6 months post treatment(1, 3 and 6 months post treatment)
- Blood pressure control to guideline recommended target blood pressure values at 1, 3 and 6 months post treatment(1, 3 and 6 months post treatment)
研究者
研究点 (10)
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