Global Pilot Study of rEnal and Hepatic coMbINed denervatIon in Subjects With Uncontrolled Hypertension With and Without High Cardiovascular Risk
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 175
- 试验地点
- 27
- 主要终点
- Change in office blood pressure
研究概览
简要总结
The purpose of the SPYRAL GEMINI Pilot Study is to evaluate that multi-organ denervation with the Gemini System is safe and provide evidence of blood pressure reduction when studied in an uncontrolled hypertensive population with and without high cardiovascular risk.
详细描述
This study is exploratory in nature and will evaluate procedural and long-term safety of multi-organ denervation (MDN) and provide preliminary efficacy data in two parallel single arm cohorts:
- Gemini Pilot Off Med: MDN for Hypertension Off Anti-hypertensive Meds and,
- Gemini Pilot On Med: MDN for Hypertension and High Cardiovascular Risk On Anti-hypertensive Meds
There is no pre-specified primary endpoint; however, the data will be used for hypothesis generation to be evaluated and confirmed in subsequent clinical investigation(s).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •All Subjects (both cohorts):
- •≥18 and ≤80 years of age.
- •Diagnosed with HTN and has a baseline office SBP ≥150 mmHg and <180 mmHg and an office DBP ≥ 90 mmHg.
- •24-hour average SBP ≥140 mmHg and <170 mmHg measured by ABPM at Baseline.
排除标准
- •Individual lacks appropriate renal artery OR common hepatic artery anatomy.
- •Prior renal or hepatic denervation.
- •History of NYHA Class III or IV heart failure within 6 months of screening visit.
- •Stroke or transient ischemic attack (TIA) within 6 months of screening visit or any history of stroke leading to permanent disability.
- •Documented Type 1 diabetes or use of insulin within 6 months.
- •Secondary cause of hypertension.
- •Documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement.
- •Estimated glomerular filtration rate (eGFR) of <40
- •Pregnant, nursing or planning to become pregnant during the study.
- •Primary pulmonary arterial hypertension.
- •History or evidence of active / suspected chronic liver or biliary disease.
- •Current or chronic pancreatitis.
研究组 & 干预措施
Gemini Pilot Off Med: Multi-Organ Denervation for Hypertension Off Anti-hypertensive Meds
干预措施: Multi-Organ Denervation Gemini System (Device)
Gemini Pilot On Med: MDN for Hypertension and High Cardiovascular Risk On Anti-hypertensive Meds.
干预措施: Multi-Organ Denervation Gemini System (Device)
结局指标
主要结局
Change in office blood pressure
时间窗: From baseline to 36 months post-procedure
次要结局
未报告次要终点