Spyral InSight Early Clinical Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 19
- 试验地点
- 3
- 主要终点
- End-stage renal disease
研究概览
简要总结
The purpose of the Spyral InSight Early Clinical Feasibility Study is to characterize the physiological response to renal nerve stimulation (RNS) in humans prior to and post renal denervation.
详细描述
This study is exploratory in nature and an early-stage clinical assessment that will evaluate procedural and long-term safety of renal nerve stimulation (RNS) when performed prior to and post renal artery denervation (RDN) with the Symplicity Spyral system, with follow-up at 1, 3, 6 and 12 months.
There is no pre-specified primary endpoint. However, the objectives of the Spyral InSight ECF study are as follows:
- To assess safety of RNS when performed prior to and post RDN.
- To characterize and quantify the physiological response to renal nerve stimulation in humans undergoing renal denervation per approved labeling.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 - 70 years of age
- •Office SBP ≥150 mmHg and <180 mmHg and DBP ≥90 mmHg
- •Individual is prescribed with one, two, or three antihypertensive medication classes
- •24-hour ABPM average of SBP ≥135 and <170 mmHg at Baseline
排除标准
- •Prior renal denervation.
- •Individual lacks appropriate renal artery Anatomy
- •Has a renal artery stent
- •Individual has an estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m2
- •Individual is taking SGLT2 inhibitors or GLP-1 agonists
- •Individual requires chronic oxygen support or mechanical ventilation
- •Primary pulmonary hypertension.
- •Secondary cause of hypertension
- •Pregnant, nursing or planning to become pregnant during the study.
- •Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement
- •Individual is currently taking anti-mineralocorticoid drugs.
研究组 & 干预措施
Renal nerve stimulation performed prior to and post renal artery denervation (RDN)
干预措施: Renal nerve stimulation (Device)
结局指标
主要结局
End-stage renal disease
时间窗: Through study completion, from enrollment to 12-month follow-up
Myocardial infarction
时间窗: Through study completion, from enrollment to 12-month follow-up
All-cause mortality
时间窗: Through study completion, from enrollment to 12-month follow-up
Incidence of stroke
时间窗: Through study completion, from enrollment to 12-month follow-up
Hospitalization for hypertensive crisis not related to non-adherence with medications
时间窗: Through study completion, from enrollment to 12-month follow-up
Significant embolic event resulting in end-organ damage
时间窗: Through study completion, from enrollment to 12-month follow-up
Renal artery intervention
时间窗: Through study completion, from enrollment to 12-month follow-up
New renal artery stenosis >70%, confirmed by angiography and as determined by the angiographic core lab
时间窗: Through study completion, from enrollment to 12-month follow-up
Vascular complications
时间窗: Through study completion, from enrollment to 12-month follow-up
Major bleeding according to TIMI definition
时间窗: Through study completion, from enrollment to 12-month follow-up
Prolonged renal vasoconstriction requiring intervention
时间窗: Through study completion, from enrollment to 12-month follow-up
Contrast induced nephropathy
时间窗: Through study completion, from enrollment to 12-month follow-up
次要结局
未报告次要终点