Evaluation of Neointimal Coverage of Everolimus-Eluting Stent and Bare-metal Stent After Implantation in STEMI Patients by Optical Coherence Tomography
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Comparison of the rate of covered struts to the EES vs BMS implanted in STEMI patients by frequency domain optical coherence tomography (FD-OCT).
研究概览
简要总结
Primary percutaneous coronary intervention (PCI) represents the preferred reperfusion strategy for patients with ST-segment elevation myocardial infarction (STEMI), since it is more effective than thrombolytic regimens in reducing adverse events, including death. Drug-eluting stents (DES) are currently being widely used in patients with STEMI. The effectiveness of DES to reduce restenosis and the need for revascularization compared with bare-metal stents (BMS) has been documented in randomized controlled trials. The first-generation DESs implanted in STEMI have been associated with delayed healing and incomplete strut coverage. Therefore, in patients with implanted DES, longer duration of dual antiplatelet therapy is needed. The second-generation DESs (ZES and EES) have been improved the drug and polymer, which have been proved to improve neointima healing compared with the first generation DESs.
However, the difference of strut coverage between EES and BMS implanted in STEMI patients is unknown. In this study, we assess the neointimal coverage at 3-month and 12-month follow-up in EES and BMS implanted in patients with STEMI by optical coherence tomography.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-75 years
- •Acute MI with ST-segment elevation, within 12 hours from symptoms onset.
- •Length of culprit lesion≤25mm.
- •Vessel size in between 2.5 and 4.0 mm.
- •Signed patient informed consent.
排除标准
- •Prior administration of thrombolytic therapy.
- •Cardiogenic shock.
- •Renal failure (Crea≥2.0mg/dL).
- •Recent major bleeding.
- •Allergy to heparin, aspirin, clopidogrel, everolimus, the polymer components of the Xience V stent, stainless steel, or contrast media.
- •Left main disease
- •Multi-vessel lesion
- •Other hemodynamically significant lesion(s) is present in the infarct vessel (or side branches)
- •Angiography demonstrates the infarct lesion to be at the site of a previously implanted stent or in bypass grafts.
- •No suitable anatomy for OCT scan.
结局指标
主要结局
Comparison of the rate of covered struts to the EES vs BMS implanted in STEMI patients by frequency domain optical coherence tomography (FD-OCT).
时间窗: 3-month
The covered strut is defined as the strut has definite neointimal over it. And the rate of covered struts was calculated as the number of covered struts divided the number of total struts.
次要结局
- Comparison of the rate of covered struts to the EES vs BMS implanted in STEMI patients by FD-OCT.(12-month)
- Major adverse cardiovascular events (MACE)(12-month)
- Comparison of the rate of malaposed struts to the EES vs BMS implanted in STEMI patients by FD-OCT.(12-month)
- Comparison of the rate of malaposed struts to EES vs BMS implanted in STEMI patients by FD-OCT.(3-month)
研究者
Yu Bo
The second affiliated hospitai of Harbin medical university
Harbin Medical University