Fractional Flow Reserve-Guided Revascularization in Atherosclerotic Renal Artery Stenosis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 19
- 主要终点
- eGFR changes
研究概览
简要总结
For patients with atherosclerotic renal artery stenosis, the results of randomized controlled trials published in recent years have failed to demonstrate that renal artery stenting is superior to optimal medical therapy. However, these studies still have limitations.
Fractional flow reserve (FFR) has been extensively studied in coronary artery disease, and it has been established that FFR-guided revascularization is superior to both angiography-guided percutaneous coronary intervention and medical therapy alone. Whether FFR can guide interventional treatment in patients with renal artery stenosis and hypertension is currently a hot topic in the field of renal artery stenosis research.
Eligible patients meeting the inclusion criteria were enrolled. Pharmacologically induced FFR values were measured as the baseline. Patients with FFR ≥ 0.8 were randomly assigned to either the medical therapy group or the stenting group, while patients with FFR < 0.8 underwent stent implantation. Changes in eGFR, 24-hour systolic blood pressure, and 24-hour diastolic blood pressure from baseline to 12 months were compared among the groups.
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
- •Renal artery diameter stenosis ≥60%;
- •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;
- •Serum creatinine < 264 μmol/L (3.0 mg/dL);
- •Affected kidney length ≥ 7.0 cm, with residual glomerular filtration rate (GFR) ≥ 10 mL/min;
排除标准
- •Unstable clinical condition rendering the patient intolerant to revascularisation therapy;
- •Urinary protein ≥2+;
- •Contrast medium allergy;
- •Renal artery anatomy unsuitable for revascularisation therapy;
- •Reference vessel diameter <3.5mm or >8mm.
- •Patients with non-atherosclerotic renal artery stenosis (such as fibromuscular dysplasia or Takayasu arteritis);
- •Reference vessel diameter < 3.5 mm or > 8 mm.
研究组 & 干预措施
stent group with FFR ≥ 0.8
Drug-induced hyperemic FFR ≥ 0.80
干预措施: Randomized to stenting (Device)
drug group with FFR ≥ 0.8
Drug-induced hyperemic FFR ≥0.80
干预措施: Randomized to optimal medical therapy (OMT) (Drug)
FFR < 0.8
Drug-induced hyperemic FFR ≥0.80
干预措施: stent implantation (Device)
结局指标
主要结局
eGFR changes
时间窗: From baseline to 12 months post-procedure
The change in eGFR(Estimated Glomerular Filtration Rate) at 12 months post-procedure compared to baseline.
次要结局
- 24h-SBP changes(From baseline to 12 months post-procedure)
- 24h-DBP changes(From baseline to 12 months post-procedure)
- non-fatal stroke(From baseline to 12 months post-procedure)
- rehospitalization for congestive heart failure(From baseline to 12 months post-procedure)
- OBP changes(From baseline to 12 months post-procedure)
- medication load changes(From baseline to 12 months post-procedure)
- stent restenosis(From baseline to 12 months post-procedure)
- perioperative complications(From baseline to 30 days post-procedure)
- Vascular Complications(From baseline to 12 months post-procedure)
- renal adverse events(From baseline to 12 months post-procedure)
- Renal Target Organ Damage(From baseline to 12 months post-procedure)
- RBR(From baseline to 12 months post-procedure)
- all-cause death(From baseline to 12 months post-procedure)
- cardiovascular death(From baseline to 12 months post-procedure)
- myocardial infarction(From baseline to 12 months post-procedure)
- UACR changes(From baseline to 12 months post-procedure)
研究者
Xiongjing Jiang
professor
Chinese Academy of Medical Sciences, Fuwai Hospital