Usefulness of the Use of Co-registration Strategy With iFR in Long and/or Diffuse Coronary Lesions
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Reduction of the average stent length implanted in the Syncvision guided group
研究概览
简要总结
Randomized controlled trial to determinate if the physiological iFR pullback evaluation with Syncvision software (intervention group) could be useful in the reduction of stent length implanted, with the potencial benefit in terms of MACEs reduction at follow-up with respect to angiographic guiding of percutaneous coronary intervention (control group).
详细描述
Physiological coronary lesion evaluation is actually a routine practice in the labs to guide percutaneous coronary intervention decision making. Unlike FFR, the new index permit us to perform an analysis of the physiological importance of every lesion and every coronary segment. This fact has allowed to create a new specific software. Syncvision show us the functional compromise of every lesion and predict the expected IFR improvement.
This potential benefit could have an extra benefit in the reduction of the implanted stent length. There are some observational study published that reported a reduction of 5 mm of stent length, but we think that the reduction could be significantly higher.
However, this reduction could be detrimental of the complete cover of plaque in this type of lesion, which has also proved to be a predictor of MACEs.
For this reason, we have proposed to perform a randomized study to define if the utilization of physiological IFR pullback evaluation in long and/or diffuse coronary lesion present advantages over classical angiographic PCI.
Study hyphotesis:
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
- None
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
- •Age higher than 18 years old.
- •Sign of inform consent
- •Patients with at least a vessel with angiographic significant lesion (long/sequential or diffuse lesion) >/= 25 mm of length where the percutaneous strategy is going to be the choice strategy.
- •Patients with stable angina, NSTEMI or STEMI (non culprit vessel)
排除标准
- •Patients with Acute Coronary Syndrome with non optimal result of culprit vessel (final TIMI flow < TIMI III, non-reflow phenomenon during the treatment, residual coronary dissection, lost or compromise of significant side branch).
- •Acute Coronary Syndrome and Left Ventricular Ejection Fraction lower than 45%.
- •Live expectancy lower than 12 months.
- •Patients with severe aortic stenosis.
- •Contraindication for dual anti platelet therapy during at least 12 months.
- •Patients with indication of bypass surgery in base to Heart Team decision.
结局指标
主要结局
Reduction of the average stent length implanted in the Syncvision guided group
时间窗: 12 months
Reduction of stent length implanted, measured in millimeters, in the group guided by Syncvision software
次要结局
- Combined endpoint of cardiac death, myocardial infarction and new revascularization of analyzed or treated vessel in the basal procedure at 12 months of follow-up(12 months)