NCT01865591Unknown早期 1 期
A Clinical Trial for the Assessment of Safety and Efficacy of the UltraSOUND Mediated InTerVentional Treatment of Resistant Hypertension
Sound Interventions, Inc.2 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2012年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Major adverse events
研究概览
简要总结
The aim of this study is to assess the potential therapeutic benefit of catheter-based renal sympathetic denervation using therapeutic unfocussed ultrasound in a single-arm feasibility trial.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Uncontrolled hypertension (defined as SBP ≥ 140 mmHg during 24Hr Ambulatory BP monitoring)
- •Current treatment with ≥ 3 anti-hypertensive drugs (including at least one diuretic)
- •Renal artery diameter ≥5mm by digital angiography
- •Accessibility of renal vasculature
排除标准
- •Estimated GFR < 45
- •Type 1 Diabetes
- •Known renovascular abnormalities (eg, renal artery stenosis, previous renal artery stenting or angioplasty)
研究组 & 干预措施
Renal denervation
Experimental
Subjects are treated with unfocussed ultrasound-based renal denervation and are maintained on baseline anti-hypertensive medications.
干预措施: Ultrasound-based Renal Denervation (Device)
结局指标
主要结局
Major adverse events
时间窗: 30 days
All cause death, renal artery occlusion, renal artery stenosis, renal infarction and/or renal failure
次要结局
- Adverse events and device complications(12 months)
- Change from baseline in creatinine(6 months)
- Change from baseline in office blood pressure measurement(30 days, 3 months, 6 months, 9 months, 12 months)
- Change from baseline in ambulatory 24-hour blood pressure measurement(6 months, 12 months)
- Change from baseline in renal artery dimensions(30 days)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
REnal SympathetiC Denervation to sUpprEss Tachyarrhythmias in ICD RecipientsVentricular TachycardiaNCT01747837Vivek Reddy48
Unknown
不适用
Renal Sympathetic Denervation in Patients With Hypertension and Paroxysmal Atrial FibrillationHypertensionAtrial FibrillationNCT01814111The First Affiliated Hospital with Nanjing Medical University100
Unknown
不适用
A Study of Non-Vascular Renal Denervation Using the Verve Medical Phoenix ™ SystemUncontrolled HypertensionHypertensionNCT05440513Verve Medical, Inc20
已完成
不适用
Impact of Sympathetic Renal Denervation- a Study in Patients After Renal TransplantationRenal TransplantationSympathetic ActivityChronic Kidney DiseaseHypertensionNCT01899456Technical University of Munich18
已完成
不适用
Full Length Versus Proximal Renal Arteries AblationHypertension, Resistant to Conventional TherapyNCT01848275The Second Affiliated Hospital of Chongqing Medical University47