RENAL ARTERY IRRADIATION FOR SYMPATHETIC RENAL DENERVATION IN PATIENTS WITH RESISTANT HYPERTENSION
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Safety-renal Artery Brachytherapy With Beta-emitting Source is Any Need for Renal Artery Intervention to Treat Renal Artery Injury Induced by the Catheter of Radiation Within 6 Months
研究概览
简要总结
The kidneys are an important regulator of blood pressure. Previous research has shown that disrupting the nerves (denervate) of the kidney may successfully decrease blood pressure. In the past, one technique that was used to treat severe high blood pressure was a surgical procedure to cut these nerves. However, this surgery is no longer commonly performed.
Another approach to disrupting these nerves is to use the Beta-Cath 3.5F system to deliver a small amount of radiation to the treatment zone. The Beta-Cath 3.5F System (Novoste) is currently approved in the United States to deliver ion dose therapy to re-narrowings that form in the coronary arteries in the heart. This trial is assessing the safety of treating patients with the Beta-Cath 3.5F System (Novoste) to denervate the nerves around the kidney to help control blood pressure in patients with uncontrolled hypertension.
- Renal artery brachytherapy with beta-emitting source is safe.
- Renal artery brachytherapy with beta-emitting source can reduce systolic/diastolic blood pressure via renal denervation mechanism within 6 months post treatment.
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
- Triple (Participant, Care Provider, Investigator)
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
- •4.2.1 GENERAL INCLUSION CRITERIA
- •Subjects must meet all of the following inclusion criteria prior to enrollment into the trial:
- •Individual is ≥ 18 and ≤ 85 years of age.
- •Individual has a systolic blood pressure (SBP) ≥ 160 mmHg (≥ 150 mmHg for type 2 diabetics) based on an average of 3 office blood pressure readings.
- •Individual is adhering to a stable (maximally tolerated dose) drug regimen including 3 or more anti-hypertensive medications for at least 1 month (including one diuretic) that is expected to be maintained for at least 6 months.
- •Individual is competent and willing to provide informed consent to participate in the trial.
- •4.2.2 ANGIOGRAPHIC INCLUSION CRITERIA
- •Individual has main renal arteries measuring <2.75 mm in diameter.
排除标准
- •Inability to sign written informed consent.
- •Individual has renal artery anatomy that is ineligible for treatment including:
- •Main renal arteries with <20 mm treatable length
- •Renal artery stenosis of ≥20% by angiography.
- •A history of prior renal artery intervention including balloon angioplasty or stenting.
- •Multiple main renal arteries in either kidney.
- •Individual has an eGFR of < 45mL/min/1.73m2, using the MDRD formula calculation.
- •Individual has had >1 hospital admission for a hypertensive crisis within the past year.
- •Individual has an Ambulatory Blood Pressure Monitoring 24 hour average SBP<135mmHg.
- •Individual has has > 1 episode(s) of orthostatic hypotension (reduction of SBP of >20 mmHg or diastolic blood pressure (DBP) of >10 mmHg within 3 minutes of standing) coupled with symptoms 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 scheduled or planned surgery or cardiovascular intervention in the next 3 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 (e.g., arm diameter too large for the cuff, arrhythmia that interferes with automatic monitor's pulse sensing and prohibits an accurate measurement).
- •Individual is pregnant, nursing or planning to be pregnant.
- •Individual has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
- •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 (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or significant anemia, or arrhythmias such as atrial fibrillation).
- •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.
结局指标
主要结局
Safety-renal Artery Brachytherapy With Beta-emitting Source is Any Need for Renal Artery Intervention to Treat Renal Artery Injury Induced by the Catheter of Radiation Within 6 Months
时间窗: up to 6 months post procedure
The primary safety endpoint for renal artery brachytherapy with beta-emitting source is any need for renal artery intervention to treat renal artery injury induced by the catheter of radiation within 6 months
Angiographic
时间窗: up to 6 months post procedure
The angiographic endpoint is defined as late loss at 6 months by offline quantitative coronary angiography (QCA)
Efficacy- Renal Artery Brachytherapy With Beta-emitting Source is Decrease in Systolic and Diastolic Blood Pressure of ≥10 mmHg at Six Months Following the Procedure.
时间窗: up to 6 months post procedure
The primary efficacy endpoint for renal artery brachytherapy with beta-emitting source is decrease in systolic and diastolic blood pressure of ≥10 mmHg at six months following the procedure.
次要结局
- Medication Changes(up to 24 months post procedure)
- Serious Adverse Events(up to 24 months post procedure)
- Safety-renal Artery Dissection or Perforation Requiring Intervention, and Serious Groin Complications Specifically.(up to 24 months post procedure)
- eGFR or New Stenosis(up to 6 months post procedure)
- Effects on Blood Pressure(up to 6 months post procedure)