NCT01632943终止不适用
A Prospective, Multi-center, Non-randomized, Controlled Trial in India to Evaluate Efficacy and Safety of Renal Denervation in the Treatment of Uncontrolled Hypertension
Medtronic Vascular2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2013年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Efficacy: Change in Office Systolic Blood Pressure from baseline to 6 months post-procedure
研究概览
简要总结
This study is to evaluate efficacy and safety of renal denervation in the treatment of uncontrolled hypertension. This study will enroll a minimum of 40 and a maximum of 45 subjects. The study will be conducted at up to 8 actively enrolling investigational sites. The primary endpoint is change in Office Systolic Blood Pressure from baseline to 6 months post-procedure.
详细描述
Estimated enrollment Start: May 2013 (estimated 90 day duration) Estimated last follow-up: September 2013 Follow-Up Duration: Subjects in the intent-to-treat population will be followed from enrollment through 6 months ±14 days for the effectiveness and safety endpoints
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individual is 18 and 80 years old at time of treatment.
- •Individual is receiving a stable medication regimen including 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic that is expected to be maintained without changes for at least 6 months.
- •Individual has an office systolic blood pressure of 160 mm Hg based on an average of 3 blood pressure readings measured at screening visits
- •Individual or legally authorized representative agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.
排除标准
- •Individual has renal artery anatomy that is ineligible for treatment including:
- •Main renal arteries with less than 4 mm diameter or with less than 20 mm treatable length
- •Multiple renal arteries where the main renal artery is estimated to supply less than 75 percent of the kidney.
- •Renal artery stenosis more than 50 percent or renal artery aneurysm in either renal artery.
- •A history of prior renal artery intervention including balloon angioplasty or stenting.
- •Individual has an estimated glomerular filtration rate of less than 45mL per min per 1.73m2, using the MDRD calculation.
- •Individual has had more than 1 in-patient hospitalization for a hypertensive crisis within the past year.
- •Individual has type 1 diabetes mellitus.
- •Individual has had 1 or more episodes of symptomatic orthostatic hypotension within the past year or during the screening process.
- •Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
- •Individual has primary pulmonary hypertension.
- •Individual has known secondary causes of hypertension, such as untreated pheochromocytoma, Cushing's Disease, coarctation of the aorta, hyperthyroidism, or hyperparathyroidism.
- •Individual has experienced a myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 6 months of the screening period, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
- •Individual has a scheduled or planned surgery or cardiovascular intervention in the next 6 months.
- •Individual has a condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement using the protocol specified automatic blood pressure monitor
- •Individual has severe cardiac valve stenosis for which, in the opinion of the Investigator, a significant reduction of blood pressure is contraindicated.
- •Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study
- •Individual is pregnant, nursing or planning to be pregnant.
- •Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
- •Individual is currently enrolled in another investigational drug or device trial. For the purposes of this protocol, participants involved in extended follow-up trials for products that were investigational but are currently commercially available are not considered enrolled in an investigational trial.
结局指标
主要结局
Efficacy: Change in Office Systolic Blood Pressure from baseline to 6 months post-procedure
时间窗: 6 months post procedure
次要结局
- Safety: Incidence of Major Adverse Events (MAE),through 6 months post-procedure(6 months post procedure)
研究者
研究点 (2)
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