Endovascular Treatment of Atherosclerotic Renal Artery Stenosis: A Prospective Randomized Controlled Study Comparing Covered Stents and Bare Metal Stents
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 15
- 主要终点
- Change in eGFR
研究概览
简要总结
Atherosclerotic renal artery stenosis is the most common cause of secondary hypertension , increasing the risk of cardiovascular and kidney-related complications. Some small-scale studies have suggested that covered stents are effective and safe, but high-quality evidence from large-scale studies in atherosclerotic renal artery stenosis remains limited.
This study aims to evaluate whether covered stents are more effective than bare metal stents in patients with atherosclerotic renal artery stenosis. Eligible participants will be randomly assigned to receive either a covered stent or a bare metal stent. Patients will be followed for 12 months to assess Changes in eGFR, 24-hour systolic blood pressure, and 24-hour diastolic blood pressure from baseline to 12 months were compared among the groups.
The results of this study may help improve treatment strategies and guide the selection of stent type for patients with this condition.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1) Renal artery diameter stenosis ≥60%; 2) Office systolic blood pressure ≥ 160 mmHg and/or office diastolic blood pressure ≥ 100 mmHg on at least two separate days without antihypertensive medication, or office systolic blood pressure ≥ 140 mmHg and/or office diastolic blood pressure ≥ 90 mmHg while on three antihypertensive drugs at conventional doses; 3) Serum creatinine < 264 μmol/L (3.0 mg/dL); 4) Affected kidney length ≥ 7.0 cm, with residual glomerular filtration rate (GFR) ≥ 10 mL/min;
排除标准
- •1) Unstable clinical condition rendering the patient intolerant to revascularisation therapy; 2) Urinary protein ≥2+; 3) Contrast medium allergy; 4) Renal artery anatomy unsuitable for revascularisation therapy; 5) Reference vessel diameter <3.5mm or >8mm. 6)Patients with non-atherosclerotic renal artery stenosis (such as fibromuscular dysplasia or Takayasu arteritis); 7)Reference vessel diameter < 3.5 mm or > 8 mm
研究组 & 干预措施
bare metal stents group
干预措施: Bare Metal Stent (Device)
covered stents group
干预措施: Covered Stent (Device)
结局指标
主要结局
Change in eGFR
时间窗: 12 months
Change in estimated glomerular filtration rate (eGFR) at 12 months compared with baseline
次要结局
- Change in 24-Hour Ambulatory Systolic Blood Pressure(12 months)
- Change in 24-Hour Ambulatory Diastolic Blood Pressure(12 months)
- Change in Office Systolic Blood Pressure(12 months)
- Change in Office Diastolic Blood Pressure(12 months)
- Change in Home Systolic Blood Pressure(12 months)
- Change in Home Diastolic Blood Pressure(12 months)
- Change in antihypertensive medication burden(12 months)
- Stent patency(12 months)
- Incidence of perioperative complications(1 month)
- MACE(12 months)
- Renal Adverse Events(12 months)
研究者
Xiongjing Jiang
Chief Physician, Department of Cardiology
Chinese Academy of Medical Sciences, Fuwai Hospital