NCT07081243招募中不适用
A Prospective, Single-group, Non-interventional, Non-blinded, Observational Study to Evaluate the Long-term Safety, Efficacy, and Durability of Symplicity Spyral Renal Denervation System in China
Medtronic Vascular1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年11月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Primary Objective: Change in systolic blood pressure (SBP) from baseline to 6 months post-procedure as measured by office blood pressure.
研究概览
简要总结
The Symplicity China study will evaluate the real-world long-term safety, efficacy, and durability of the Symplicity Spyral system in a population of approximately 500 renal denervation treated subjects with up to 36 months of follow up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older.
- •Patients diagnosed with resistant hypertension or antihypertensive drug intolerance and treated with Symplicity Spyral Renal Denervation System. Resistant hypertension, defined as having an office systolic blood pressure (SBP) ≥140 mmHg despite appropriate lifestyle measures and being treated with three or more antihypertensive medications (including a diuretic) for more than 3 months; or drug intolerance, defined as patients who cannot tolerate medication due to contraindications or adverse effects.
- •The patient voluntarily undergoes renal denervation; the patient has been informed of the observational nature of the study; the patient voluntarily provides written informed consent ("Patient Informed Consent Form") and willingly participates in the study.
排除标准
- •At least one main renal artery with a diameter less than 3 mm or greater than 8 mm.
- •Presence of fibromuscular dysplasia.
- •Renal artery stent placement within 3 months prior to the procedure.
- •Presence of Renal artery aneurysms.
- •Presence of more than 50% stenosis in any treatable vessel.
- •Present of renal or adrenal tumors.
- •Iliac/femoral artery stenosis prevents catheter insertion.
结局指标
主要结局
Primary Objective: Change in systolic blood pressure (SBP) from baseline to 6 months post-procedure as measured by office blood pressure.
时间窗: 6 months post-procedure
次要结局
- Changes in office blood pressure(1, 3, 6, 12, 24 and 36 months post-procedure)
- Changes in home blood pressure(1, 3, 6, 12, 24 and 36 months post-procedure)
- Changes in 24-hour ambulatory blood pressure(1, 3, 6, 12, 24 and 36 months post-procedure)
- Changes of Number of medications(1, 3, 6, 12, 24 and 36 months post-procedure)
- Changes of Medication burden(1, 3, 6, 12, 24 and 36 months post-procedure)
- Proportion of subjects achieving blood pressure reduction and control to ≤140 mmHg (measured by OBP, HBP, and ABPM)(1, 3, 6, 12, 24 and 36 months post-procedure)
- Event rates(1, 3, 6, 12, 24 and 36 months post-procedure)
研究者
研究点 (1)
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