NCT06567938招募中不适用
Intravascular Ultrasound-Guided or Angiography-Guided Percutaneous Coronary Intervention in Patients With Chronic Kidney Disease: The IVUS-CKD Trial
First Affiliated Hospital Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 1,528 人开始时间: 2024年7月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,528
- 试验地点
- 1
- 主要终点
- Target vessel failure (TVF), including cardiac death, target vessel myocardial infarction (MI), or clinically driven target vessel revascularization (TVR)
研究概览
简要总结
The IVUS-CKD study is a prospective, randomized controlled, multicenter trial to determine whether the intravascular ultrasound (IVUS)-guided percutaneous coronary intervention is superior to the angiography-guidance in chronic kidney disease (CKD) patients with respect to target vessel failure (TVF) at 12 months after randomization.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CKD patients with eGFR<60 mL/min/1.73 m^2
- •De novo coronary lesion suitable for second-generation metallic drug-eluting stent placement and IVUS imaging
- •Signed written informed consent
排除标准
- •Onset of STEMI within 24 hours or emergent angiography
- •Pregnant or childbearing women
- •Co-morbidity with an estimated life expectancy of < 1 year
- •LVEF ≤ 30%
- •Cardiogenic shock or hemodynamic instability
- •Severe hepatic dysfunction, defined as ALT or AST more than 5 times the ULN
- •PCI within the previous 12 months
- •Target lesion of stent thrombosis or in-stent restenosis
- •Any planned non-cardiac surgery within 12 months
- •Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk
- •Current enrolment in other clinical trials
- •Contraindication to anti-platelet agents
- •History of intracranial or gastrointestinal bleeding requiring transfusion or surgical intervention for control (excluding hemorrhoid)
- •Chronic total occlusion lesion with unsuccessful guidewire crossing
- •Current intake of nephrotoxic medications (e.g., nonsteroidal anti-inflammatory drugs except acetylsalicylic acid, phenylbutazone, aminoglycosides, amphotericin B, polymyxin, platinum complexes)
- •Immune-related kidney disease or on hormone therapy (e.g. lupus nephritis, IgA nephropathy)
- •Planned exposure to contrast within 72 h after the procedure, intravascular administration of contrast within the previous 5 days
- •Intake of anticoagulants
- •Hemoglobin <60 g/L
- •Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial
- •Patients allergic to metals or contrast
结局指标
主要结局
Target vessel failure (TVF), including cardiac death, target vessel myocardial infarction (MI), or clinically driven target vessel revascularization (TVR)
时间窗: 12 months
The difference in TVF will be calculated from 0 month to 12 months between IVUS- and Angiography-guidance groups.
次要结局
- Hierarchical composite of target vessel failure(12 months)
- 30-day cardiorenal endpoint(30 days)
- Cardiac death(12 months)
- Target vessel MI(12 months)
- Clinically driven target vessel revascularization(12 months)
- Spontaneous MI(12 months)
- Target vessel failure excluding periprocedural MI(12 months)
- Clinically driven target lesion revascularization(12 months)
- Target lesion failure(12 months)
- Major adverse cardiovascular event(12 months)
研究者
研究点 (1)
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