Heterogeneity of Neointimal Healing Following Biodegradable-polymer Drug-Eluting Coronary Stent Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Heterogeneous neointimal healing
研究概览
简要总结
The objective of this study is a comparative evaluation of Orsiro stent and of Resolute Integrity stent in terms of the extent of neointima formation at 4 months after implantation using optical coherence tomography (OCT).
详细描述
About 50 patients with clinical evidence of ischemic heart disease and / or a positive functional study and documented stable angina pectoris (Canadian cardiovascular society classification (CCS)1, 2, 3 or 4), or documented silent ischemia in de-novo, native, previously unstented vessel in Tyumen Cardiology Center,will be randomly assigned undergoing implantation of Orsiro stent or Resolute Integrity stent (in a 1:1 ratio).
All of the patients will receive 12 months dual antiplatelet therapy and they will be followed (at the outpatient clinic) for up to 1 year. The follow-up visits will be conducted at 4 months (including angiographic/OCT investigation), and 1 year post percutaneous coronary intervention(PCI),in order to observe the Primary Endpoint and Secondary Endpoints.
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
- Single (Participant)
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 > 18 years;
- •Patients with symptoms of stable angina and/or presence of a positive functional test for ischemia;
- •Patient is eligible for percutaneous coronary intervention (PCI);
- •Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee of the respective clinical site.
排除标准
- •Target lesion involving a bifurcation with a side branch ≥2.0 mm in diameter;
- •Target lesion located in the left main stem;
- •Target lesion is located or supplied by an arterial or venous bypass graft;
- •Lesion located very distally, difficult to be imaged by OCT;
- •Co-morbidities that could interfere with completion of study procedures, or life expectancy less than 1 year;
- •Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study;
- •Patient underwent target vessel revascularization with a DES;
- •Patient presenting with acute myocardial infarction with ST elevation;
- •Cerebrovascular accident within the past 12 months;
- •Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl);
- •Patient receiving oral anticoagulants
研究组 & 干预措施
Resolute Integrity
Implantation of a Resolute Integrity® zotarolimus eluting coronary stent (drug-eluting stent, DES)
干预措施: Resolute Integrity® stents (Device)
Orsiro
Implantation of a Orsiro® biolimus a9 eluting coronary stent (drug-eluting stent, DES)
干预措施: Orsiro stents (Device)
结局指标
主要结局
Heterogeneous neointimal healing
时间窗: 4 ± 1 months
Endothelial coverage by Heterogeneous neointima of the stent struts assessed by optical coherence tomography
次要结局
- Angiographic reference vessel diameter(4 ± 1 months)
- Stent Thrombosis(12 months)
- Malapposed stent struts(4 ± 1 months)
- Neointimal growth(4 ± 1 months)
- Uncovered stent struts(4 ± 1 months)
- Angiographic minimal lumen diameter(4 ± 1 months)
- Angiographic diameter stenosis(4 ± 1 months)
- Binary restenosis(4 ± 1 months)
- Clinical composite endpoints(12 months)
- Angiographic late lumen loss(4 ± 1 months)