NCT04311086已完成不适用
Global Clinical Study of Renal Denervation in the Distal Main and First Order Branch Renal Arteries Using the Symplicity Spyral™ Multi-electrode Renal Denervation System (SPYRAL DYSTAL)
Medtronic Vascular11 个研究点 分布在 4 个国家目标入组 128 人开始时间: 2020年6月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 11
- 主要终点
- Change in Systolic Blood Pressure (SBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
研究概览
简要总结
The objective of this single arm interventional study is to determine if renal denervation performed in the distal main and first order branch renal arteries is as effective in reducing blood pressure as the procedural approach used in the SPYRAL HTN-OFF MED clinical study.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Individual has office systolic blood pressure (SBP) ≥ 150 mmHg and <180 mmHg and a diastolic blood pressure (DBP) ≥ 90 mmHg after being off medications.
- •Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥ 140 mmHg and < 170 mmHg.
- •Individual is willing to discontinue current antihypertensive medications
排除标准
- •Individual has estimated glomerular filtration rate (eGFR) of <
- •Individual has type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus.
- •Individual has one or more episodes of orthostatic hypotension.
- •Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
- •Individual has primary pulmonary hypertension.
- •Individual is pregnant, nursing or planning to become pregnant.
- •Individual has frequent intermittent or chronic pain that results in treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for two or more days per week over the month prior to enrollment.
- •Individual has stable or unstable angina within 3 months of enrollment, myocardial infarction within 3 months of enrollment; heart failure, cerebrovascular accident or transient ischemic attack, or atrial fibrillation at any time.
- •Individual works night shifts.
结局指标
主要结局
Change in Systolic Blood Pressure (SBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
时间窗: From Baseline (SV2) to 12 months post-procedure
次要结局
- Incidence of Increase in Serum Creatinine >50%(From baseline (SV2) to 12 months post-procedure)
- Change in Office Systolic Blood Pressure (SBP)(From Baseline (SV2) to 12 months post-procedure)
- Change in Systolic Blood Pressure (SBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)(From Baseline (SV2) to 3 months post-procedure)
- Change in Diastolic Blood Pressure (DBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)(From Baseline (SV2) to 12 months post-procedure)
- Change in Office Diastolic Blood Pressure (DBP)(From Baseline (SV2) to 12 months post-procedure)
- Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events(From Baseline (SV2) to 12 months post-procedure)
- Incidence of Major Bleeding According to TIMI Definition(From baseline (SV2) to 12 months post-procedure)
- Incidence of Achieving Target Office Systolic Blood Pressure (SBP)(12 months post-procedure)
- Incidence of Renal Artery Re-intervention(From baseline (SV2) to 12 months post-procedure)
- Incidence of Myocardial Infarction(From baseline (SV2) to 12 months post-procedure)
- Incidence of Stroke(From baseline (SV2) to 12 months post-procedure)
研究者
研究点 (11)
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