NCT01080859已完成不适用
Early Coverage and Vessel Wall Response of the Bio-Active-stent and Everolimus-Eluting Stent Implanted in Acute Coronary Syndrome Assessed By Optical Coherence Tomography (BASE-OCT)
The Hospital District of Satakunta1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年12月最近更新:
适应症
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
- 1
- 主要终点
- Uncovered stent struts
研究概览
简要总结
The purpose of the trial is to evaluate the completeness of struts coverage and vessel wall response (strut malapposition, neoin-timal formation) to the bio-active-stent (BAS) versus ever-olimus-eluting stent (EES) implanted for the treatment of the culprit lesion in acute coronary syndrome.
详细描述
A prospective, randomized and controlled study comparing the coverage of the BAS and EES implanted in acute coronary syndrome.
Clinical follow-up at 1, 6, 12 and 18 months. OCT analysis at the time of the 6 to 8 months follow-up.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is ≥ 18 years old;
- •The patient is presenting with acute coronary syndrome, and according to hospital routine practice, eligible for percutaneous coronary intervention;
- •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
- •Lesions in coronary artery bypass grafts
- •Left main disease
- •Killip class III-IV
- •Allergy to aspirin / thienopyridine
- •Patient in anticoagulation therapy
- •No suitable anatomy for OCT scan
- •Ostial lesion
- •Tortuosity anatomy
- •Very distal lesion
- •Vessel size > 3.75 mm
结局指标
主要结局
Uncovered stent struts
时间窗: 6-8 months
OCT number of uncovered stent struts for BAS versus EES.
次要结局
- Cardiac death,MI, stent thrombosis (ST) and TLR.(1, 6, 12 and 18 months)
研究者
研究点 (1)
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