Coronary Flow Reserve in Patients With Bio-active Stent or Everolimus-eluting Stent Implanted in Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Coronary flow reserve (CFR)
研究概览
简要总结
The aim of the trial is to assess coronary artery reactivity using adenosine-induced coronary flow reserve (CFR) by transthoracic echocardiography in patients with Bio-active stent (BAS) and Everolimus-eluting stent (EES) distal to the original culprit lesion at 6-8 months.
详细描述
Objective: The aim of the trial is to assess coronary artery reactivity using adenosine-induced coronary flow reserve (CFR) by transthoracic echocardiography in patients with Bio-active stent (BAS) and Everolimus-eluting stent (EES) distal to the original culprit lesion at 6-8 months.
Design: BASE-CFR is a substudy of the larger randomized multicenter BASE-ACS trial comparing bio-active Titan stent to everolimus-eluting stent in patients with acute coronary syndrome. CFR assessment will be performed at 6-8 months after stent implantation at the same time with OCT assessment. In-stent restenosis will be ruled out using OCT.
Primary endpoint: CFR at 6-8 months after stent implantation.
Secondary endpoint: Coronary flow velocity at baseline and during adenosine-induced hyperemia 6-8 months after stent implantation..
Association of CFR to unendotheliazed stent struts and stent malapposition.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is enrolled to the BASE-ACS trial. Treated culprit lesion is in the proximal or middle LAD
- •Patient or the patient's legal representative has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Ethics Committee of the respective clinical site
排除标准
- •Diabetes mellitus
- •Treated stent position other than LAD proximal or middle.
- •Bifurcation lesions
- •Renal impairment (creatinine >120 mmol/L)
- •No suitable anatomy for OCT scan or CFR measurement
结局指标
主要结局
Coronary flow reserve (CFR)
时间窗: 6-8 months after stent implantation
CFR at 6-8 months after stent implantation
次要结局
- Coronary flow velocity(at baseline and during adenosine-induced hyperemia)
- Association of CFR to unendotheliazed stent struts and stent malapposition(6-8 months)