First in Man Study to Evaluate the Safety and Efficacy of Disposable Intravascular Ultrasound Ablation Catheters and Ultrasound Ablation Instrument in the Treatment of Essential Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Procedural success
研究概览
简要总结
To evaluate the safety and feasibility of disposable intravascular ultrasound ablation catheter and ultrasound ablation instrument in the treatment of essential hypertension.
详细描述
Feasibility Research This is a prospective, small-sample, single-group study. A total of 10 subjects are planned to be included in this study. Disposable intravascular catheter and instrument are used for intravascular ultrasound ablation. All participants will be followed up by telephone or outpatient at 1, 2 and 6 months post-procedure, with procedural success rate as the primary endpoint. At the same time, the incidence of adverse events will be observed to make a preliminary evaluation of the safety and feasibility of disposable intravascular catheter and instrument, and to provide data support for the second-stage confirmatory study.
In feasibility research, statistical analysis of data will be performed after 30 days postoperative follow-up of the subjects, and the safety and feasibility of disposable intravascular catheter and instrument will be preliminarily evaluated before entering the stage of confirmatory 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18 and≤80 years old, no gender limitation;
- •Two or more antihypertensive drugs should be statically taken for at least 4 weeks before randomization and the prescribed dose should be ≥ 50% of the manufacturer's maximum dose， angiotensin-converting enzyme inhibitor (ACEI) (or angiotensin-Ⅱ receptor antagonist (ARB)) and calcium channel blocker (CCB) (or thiazide diuretic) are required to be used in combination. Blood pressure meets the following conditions: 1) office systolic blood pressure (SBP)≥150mmHg and<180mmHg; 2) office diastolic blood pressure (DBP) ≥90mmHg;
- •24-hour ambulatory systolic blood pressure: ≥135 mmHg and <170 mmHg;
- •A recorded history of essential hypertension;
- •Understands the purpose of this study, and is willing to sign the Informed Consent and complete clinical follow-up.
排除标准
- •Ineligible renal artery anatomy including : (1) multiple renal arteries, (2) main renal artery diameter <4mm or length <20mm, (3) renal artery stenosis > 50% in the main renal artery, (4) atherosclerosis of the renal artery, renal artery aneurysm, fibromuscular dysplasia or calcification, (5) pre-existing renal stent, (6) single kidney
- •Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2
- •Type Ⅰ diabetes mellitus or poorly controlled type Ⅱ diabetes mellitus (defined as plasma Hb1Ac≥ 9.0% or 24-hour urinary protein quantification >1g/24h or proliferative retinopathy)
- •Postural hypotension
- •Recent vascular events: Experienced acute myocardial infarction, unstable angina, syncope, or cerebrovascular accident within 3 months of the screening period
- •Possible secondary hypertension
- •Respiratory support: The individual requires long-term oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
- •Life expectancy <1 year
- •Female who is pregnant, nursing, or planning to become pregnant
- •Subjects who are currently enrolled in another clinical trial and have not completed their primary endpoint
- •Subjects who are allergic to contrast medium
- •Subjects who are unsuitable for the trial ，because of poor patient compliance or other reasons judged by the investigator
结局指标
主要结局
Procedural success
时间窗: Before discharge (post-procedure), up to 7 days
Procedural success was defined as the absence of renal arterial related complication during the subject's hospitalization based on the device success.
次要结局
- Change in average 24-hour/night-time ambulatory Systolic Blood Pressure (SBP)(1 month, 2months, 6 months post-procedure)
- Change in average 24-hour/daytime/night-time ambulatory Diastolic Blood Pressure (DBP)(1 month, 2months, 6 months post-procedure)
- Device success(immediate post-procedure)
- Change in average daytime ambulatory Systolic Blood Pressure (SBP)(1 month, 2months, 6 months post-procedure)
- Change in office diastolic blood pressure(1 month, 2 months, 6 months post-procedure)
- Significant embolic events resulting in end-organ damage(1 month, 2 months, 6 months post-procedure)
- Incidence of acute myocardial infarction, stroke, transient ischemic attack, cerebrovascular accident(1 month, 2 months, 6 months post-procedure)
- End-stage renal disease(1 month, 2 months, 6 months post-procedure)
- Incidence of achieving target office systolic blood pressure(1 month, 2 months, 6 months post-procedure)
- Incidence of adverse events(1 month, 2 months, 6 months post-procedure)
- Change in office systolic blood pressure(1 month, 2 months, 6 months post-procedure)
- Renal artery or vascular complications requiring intervention(1 month, 2 months, 6 months post-procedure)
- Significant (50%) and severe (75%) new onset renal stenosis(6 months post-procedure)
- Severe access site complications(1 month, 2 months, 6 months post-procedure)
- Interface friendliness of ultrasonic ablation instrument(immediate post-procedure)
- Stability of ultrasonic ablation instrument(immediate post-procedure)