NCT02392351已完成不适用
A Boston Scientific Clinical Trial of Renal Denervation Using the Vessix Reduce™ Catheter and Vessix™ Generator for the Treatment of HyperTensioN: REINFORCE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 24
- 主要终点
- OBSERVATIONAL: Change (Mean Reduction) in Average 24-hour Ambulatory Systolic Blood Pressure (ASBP) Through 8 Weeks
研究概览
简要总结
The REDUCE HTN: REINFORCE study is being conducted to determine whether the Vessix Reduce™ Catheter and Vessix™ Generator for the treatment of uncontrolled hypertension (off-treatment office systolic blood pressure ≥150 mmHg and ≤180 mmHg) shows acceptable performance at 8 weeks when compared to a masked procedure (renal angiogram).
详细描述
Prospective, multicenter, single blinded, randomized, controlled, pilot study. Subjects will be randomized to renal denervation treatment or masked renal angiogram procedure (2:1).
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
- Single (Participant)
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
- •Age ≥18 and ≤75 years
- •OSBP ≥150 mmHg and ≤180 mmHg based on an average of 3 office-based blood pressure measurements
- •Average 24-hour ASBP ≥135 mmHg and ≤170 mmHg
- •For each kidney, a main renal artery, with or without accessory renal arteries, with diameter ≥3.0 mm and ≤7.0 mm and length ≥20.0 mm
- •Agrees to have all study procedures performed, and is competent and willing to provide written, informed consent
排除标准
- •Stenosis >30% or renal artery aneurysm in either renal artery
- •Fibromuscular dysplasia (FMD)
- •Known causes of secondary HTN
- •Type 1 diabetes mellitus
- •eGFR <40 mL/min/1.73m2
- •Known ejection fraction of <30% or heart failure that required hospitalization in the previous 6 months
- •Severe valvular heart disease
- •≥1 episode(s) of orthostatic hypotension not related to medication changes (reduction of SBP of ≥20 mmHg or DBP of ≥10 mmHg within three minutes of standing) coupled with symptoms within the past year or during screening
结局指标
主要结局
OBSERVATIONAL: Change (Mean Reduction) in Average 24-hour Ambulatory Systolic Blood Pressure (ASBP) Through 8 Weeks
时间窗: Through 8 weeks
Change (mean reduction) in average 24-hour Ambulatory Systolic Blood Pressure (ASBP) through 8 weeks post randomization in subjects treated with renal denervation (Test) and subjects treated with masked procedure (Control)
次要结局
- Congestive Heart Failure(24 Months)
- Renal Artery Dissection or Perforation Requiring Intervention(4 weeks)
- All-Cause Death(24 Months)
- Vascular Complications(4 weeks)
- Number of Hospitalizations Due to Severe Hypotension/Syncope(Through 6 months)
- Significant New Renal Artery Stenosis(6 months)
- Mean Reduction in Average 24-hour Ambulatory Systolic Blood Pressure at 6 Months(6 Months)
- Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure Through 6 Months(6 Months)
- Mean Reduction in Average 24-Hour Ambulatory Systolic Blood Pressure(12 Months)
- Number of Participants With Renal Failure(24 Months)
- Mean Reduction in Average Office-based Systolic Blood Pressure(24 Months)
- Mean Reduction in Average Office-based Diastolic Blood Pressure(24 Months)
- Percent of Subjects at Target Blood Pressure(24 Months)
- Stroke(24 Months)
- Significant Embolic Event Resulting in End-organ Damage or Intervention to Prevent it(4 weeks)
- Number of Subjects Utilizing Anti-hypertensive Medications(6 months)
- Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure(12 Months)
- Number of Participants With Hypertensive Crisis(24 Months)
- Myocardial Infarction(24 Months)
研究者
研究点 (24)
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