NCT05858190尚未招募不适用
Comparison of Drug Eluting Balloon and Plain Old Balloon for the Treatment of Non-atherosclerotic Renal Artery Stenosis--A Protocol of a Multicenter Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- Primary patency rate
研究概览
简要总结
The study will test the efficacy of drug eluting balloon(DEB) for non-atherosclerotic renal artery stenosis. The DEB (paclitaxel eluting balloon) will be used in the intervention group, while the plain old balloon(POB) will be used in the control group. The primary outcome is the effect of blood pressure control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18y and 45y.
- •with ≥ 60% stenosis in at least one renal artery.
- •with hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg).
- •patients with no severe renal insufficiency (eGFR>30 ml/min, length of the kidney ≥ 7cm).
- •Good compliance.
- •with informed consent.
排除标准
- •With apparent atherosclerotic risk factors.
- •With renal intervention or surgery history.
- •With congenital anatomical anomaly.
- •With severe renal insufficiency (length of the target kidney < 7cm, total
- •eGFR<30ml/min, divided eGFR of the target kidney<8 ml/min)
- •With contraindication for antiplatelet therapy.
- •With severe cardiopulmonary insufficiency.
- •Allergic to contrast medium
- •Being pregnant or preparing for pregnancy
- •With active cancer.
- •Life expectancy < 12 month
- •Without informed consent
结局指标
主要结局
Primary patency rate
时间窗: 9 months
uninterrupted patency with no procedures performed on or at the margins of the treated segment or bypass
次要结局
未报告次要终点
研究者
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Unknown
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