Remote Ischemic Preconditioning on the Prognosis of Patients With Elective PCI Using Drug-coated Balloon
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 430
- 试验地点
- 1
- 主要终点
- TLF
研究概览
简要总结
Drug-coated balloon is being used more and more widely for the advantage of intervention without implantation.
But the balloon needs to be released long enough to be effective. Prolonged balloon dilation resulting in the cessation of blood flow in the distal vessels, especially large vessels, may result in severe ischemia in the patient.
RIPC can enhance patients' tolerance to ischemic events, so we believe that RIPC application before the use of drug balloon for PCI can improve patients' ischemic symptoms, thus increasing the release time of drug balloon and improving the effect.
详细描述
Some patients receiving PCI cannot tolerate the symptoms of myocardial ischemia caused by the release of the drug balloon for a long time and even lead to the occurrence of adverse events.RIPC was found to improve tolerance to myocardial ischemia in patients.
At the same time, it can open collateral circulation and improve the tolerance of myocardial ischemia in patients.Therefore, this study designed a parallel control group. The experimental group was treated with RIPC before PCI, while the control group was not treated before PCI.
The operator does not know whether the patient has undergone RIPC or not, and the operator decides the time of drug balloon release according to the symptoms of the patient during the operation.Angiography was performed at 6 months, and QCA was used to determine late lumen loss at 1 year.The 1-year incidence of target lesion failure events was assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Before the operation, the nurse chooses the patient to perform RIPC or not according to a predefined random method, and then the operation is performed by the operator.
The operator did not know if the patient had undergone RIPC. Outcome evaluators also did not know the grouping of patients
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diameter stenosis>=50% by visual estimation intend to undergo drug-coated balloon implantation
- •Target vessel diameter> 2.5mm
排除标准
- •Chronic Total Obstructive lesion
- •Diagnose patients with acute myocardial infarction <24 hours
- •Can't tolerate or not suitable for RIPC
- •Severe hepatic and renal insufficiency
- •Expected survival <1 year
- •Severe calcification needing rotational atherectomy
- •Intolerable to dual antiplatelet therapy
结局指标
主要结局
TLF
时间窗: 12 months
TLF, a composite of cardiac death, target vessel-related myocardial infarction (MI; not clearly attributed to a nontarget vessel and excluding periprocedural MI), or clinically indicated target lesion revascularization (TLR)
次要结局
- DCB expansion time(less than 120 seconds (On the 1 day of PCI))
- Late lumen loss of target vessel（mm）(6 months)