Comparison of Drug-eluting Balloon and Plain Balloon for Treatment of Non-atherosclerotic Renal Artery Stenosis: a Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Clinical benefit rate(cure or improvement of hypertension)
研究概览
简要总结
Efficacy of drug eluting balloon(DEB) for non-atherosclerotic renal artery stenosis will be tested in this study. The intervention group will be treated with paclitaxel eluting balloon. The control group will be treated with plain old balloon(POB). The primary endpoint is efficacy of blood pressure control.
详细描述
Renal artery stenosis is common cause for hypertension in young people. It could be treated with open surgery or endovascular intervention. Open surgery has relatively high complication rate. Endovascular intervention is micro-invasive but with high restenosis rate. Drug eluting balloon(DEB) has been demonstrated to be effective for preventing restenosis in peripheral arteries. This study aims to test the efficacy of drug eluting balloon for non-atherosclerotic renal artery stenosis. The intervention group will be treated with paclitaxel eluting balloon. The control group will be treated with plain old balloon. The primary endpoint is efficacy 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)
盲法说明
The patients are randomly allocated into intervention and control group. The investigator and outcomes assessor only kwow the random number. The participants will not be told the exact group that they were allocated.
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
Clinical benefit rate(cure or improvement of hypertension)
时间窗: 9 months
Cure: diastolic blood pressure \<90 mm Hg and systolic blood pressure \<140 mm Hg off antihypertensive medications. Improvement: diastolic blood pressure \<90 mm Hg and/or systolic blood pressure \<140 mm Hg on the same or reduced number of medications (or reduced number of defined daily doses as described by the World Health Organization ) or a reduction in diastolic blood pressure by at least 15 mm Hg on the same or reduced number of medications
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
- Bail-out stenting rate(during the procedure)
- Clinical benefit rate(1, 3,6,12 months)
- Technical success rate(immediately after intervention)
- complication rate(within 30 days post-intervention)
- primary patency rate(6,12 months)
- secondary patency rate(9, 12 months)
- Target lesion revascularization(9,12 months)
- Renal function(6,9,12 months)