NCT01835535Unknown2 期
Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Renal Denervation in Patients With Resistant Hypertension
适应症
干预措施
试验速览
- 阶段
- 2 期
- 发起方
- Cardiosonic
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in office Systolic Blood Pressure (SBP) from baseline to 6-month
研究概览
简要总结
The TIVUS II is a prospective, multicenter, non-randomized, open-label clinical study of the safety and performance of the TIVUS™ System consisting of three (3) concurrent cohorts:
- TIVUS™ Severe Resistant HTN Cohort
- TIVUS™ Moderate Resistant HTN Cohort
- TIVUS™ Failed RF Therapy Cohort
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
- •Patient is ≥ 18 and ≤ 80 years of age
- •For Cohort A: Documented office systolic blood pressure > 160 mmHg (> 150 mmHg for diabetic patients); For Cohort B: Documented office systolic blood pressure > 140 mmHg (> 130 mmHg for diabetic patients); For Cohort C: Documented office systolic blood pressure > 150 mmHg (> 140 mmHg for diabetic patients)
- •Documented 24 hour systolic ABPM > 135 mmHg
- •Adherence to a stable drug regimen
- •For patients in Cohort C only: Documented renal denervation procedure with any RF technology 12 months or more prior to screening
- •Suitable renal artery anatomy
- •Male or non-pregnant / non-lactating female
- •Patient understands the nature of the procedure and provides written informed consent
- •Patient is willing and able to comply with the specified study requirements and follow-up evaluations
排除标准
- •eGFR < 45mL/min/1.73m2
- •Documented primary pulmonary hypertension
- •Patient experienced >1 episode of orthostatic hypotension coupled with syncope
- •Documented indicator of a secondary renal hypertension
- •History of myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months
- •Planned major surgery or cardiovascular intervention in the next 6 months
- •Surgery or cardiovascular intervention in the previous 3 months
- •Hemodynamically significant valvular heart disease
- •Severe debilitating lung disease
- •Patient on anticoagulant therapy that cannot be temporarily withheld for performing catheterization
- •Patient has a single functioning kidney
- •Documented thrombocytopenia, clotting disorders or aortic aneurysms
- •Moribund patient, or patient with comorbidities limiting life expectancy to less than one year
- •Contraindication to recommended study medications or intravascular contrast material that cannot be adequately controlled with pre-medication
- •Concurrent enrollment in another trial
- •Main renal arteries < 4 mm in lumen diameter or < 20 mm in length
- •Aorto-renal angle that prevents a safe cannulation of the renal artery
- •Severe common femoral artery, common and/or external iliac artery, renal, iliac or aortic calcification or tortuosity that may compromise the safe performance and completion of the procedure
- •Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery
- •Any renal artery stenosis > 50% by visual assessment
- •Any renal artery aneurysm in either renal artery
- •A history of prior renal artery balloon angioplasty or stenting (for patients in Cohort A and B only, also a history of prior renal denervation at any time)
研究组 & 干预措施
Severe Resistant HTN
Experimental
Patients presenting with resistant hypertension and office systolic blood pressure of 160 mmHg (150 mmHg for DM) or greater
干预措施: TIVUS (Device)
结局指标
主要结局
Change in office Systolic Blood Pressure (SBP) from baseline to 6-month
时间窗: 6 month
次要结局
- Blood pressure reduction(1 year)
- Procedural complications(30 day)
- Major Adverse Events (MAE)(1 year)
- Cardiovascular complications(1 year)
- Preservation of renal function(1 year)
研究者
研究点 (1)
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