Randomized Controlled Study of the Traditional Percutaneous Coronary Intervention and Intervention Using Optical Coherence Tomography of Incomplete Stent Adhesion and Extent of the Formation of Neointima by Resolute Zotarolimus-eluting Stent Insertion
试验速览
- 阶段
- 不适用
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- ratio of the stent strut
研究概览
简要总结
Optical coherence tomography (OCT) after the stent procedure to improve the adhesion and expansion, or incomplete uncovered struts attached to the main track. OCT in clinical areas by improving the parameters of the best stent will be useful. However, for better results for optical coherence tomography in percutaneous interventions have little useful data on the role. Randomized controlled study of the traditional percutaneous coronary intervention and intervention using 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Single lesion in a Single vessel
- •Reference vessel diameter 2.5 - 3.5 mm
- •Lesion length ≤ 34 mm and ≤ 34 mm stent length
- •Stable angina requiring revascularization, patients with unstable angina
- •The patient has no difficulty to enforce the follow-up angiography
- •Patient is ≥ 20 years old
排除标准
- •Lesions with graft vessel, thrombosis, restenosis, and bifurcation requiring 2 stents
- •Reference vessel diameter < 2.5 mm or > 4.0mm
- •Contraindication to anti-platelet agents
- •Treated with any DES within 3 months at other vessel
- •Creatinine level ≥ 2.0 mg/dL or ESRD
- •Severe hepatic dysfunction (3 times normal reference values)
- •Patients with LVEF < 30%
- •Life expectancy 1 year
- •Lesions with CTO or left main
- •Target vessel of ST-elevation MI
- •Lesions requiring overlapped stenting or more than 2 DES in each vessel
- •Heavy calcified lesions (definite calcified lesions on angiogram)
- •Far distal or tortuous lesions having difficulties in OCT evaluation or follow-up OCT
- •Pregnant women or women with potential childbearing
研究组 & 干预措施
DM, angio group
干预措施: percutaneous coronary intervention (Procedure)
DM, OCT group
干预措施: OCT-guided percutaneous coronary intervention (Procedure)
non DM, angio group
干预措施: percutaneous coronary intervention (Procedure)
non DM, OCT group
干预措施: OCT-guided percutaneous coronary intervention (Procedure)
结局指标
主要结局
ratio of the stent strut
时间窗: Angiographic follow-up with OCT at 6 months
次要结局
未报告次要终点