Optical Coherence Tomography Imaging Explores Long-term vasculAR Response and Healing profIle After successFul coronarY Stenting in Chronic Total Occlusion
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- long-term stent thrombosis
研究概览
简要总结
True-false-true occurred during wire penetration in coronary CTO procedure. Subintimal stenting influences vascular response. Intravenous ultrasound confirmed wire position in the procedure. Then stenting procedure was performed. Optical coherence tomography was used for exploring long-term vascular response and healing profile after successful coronary stenting in CTO lesions.
详细描述
Chronic total occlusions (CTOs) are defined as coronary lesions with thrombolysis in myocardial infarction (TIMI) grade flow of 0 and present for more than 3 months. CTO is commonly recognized as the toughest lesion subset to be treated by percutaneous coronary interventions. With the remarkable progress in the technologies and techniques achieved in the PCI for CTO over the last decade, the rate of procedural success increased to 80-90%. Chronic total occlusion is associated with a higher incidence of malapposition and uncovered stent struts. At present, four strategies were used for CTO lesions, including: ante-grade wire escalation, ante-grade dissection reentry (ADR), retro-grade wire escalation, and retrograde dissection reentry (RDR). True-false-true occurred during wire penetration. Subintimal stenting influences vascular response. Intravenous ultrasound (IVUS) confirmed wire position in the procedure. Then stenting procedure was performed according to standard routine. Optical coherence tomography (OCT) was used for exploring long-term vascular response and healing profile after successful coronary stenting in CTO lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18~85 years old;
- •Agree percutaneous coronary intervention without related contraindications;
- •Chronic total occlusion confirmed by clinical and angiographic data, predicted high successful rate of stent implantation;
- •Subjects (or legal guardians) understanding the testing requirements and procedures, and providing written informed consent.
排除标准
- •Subjects associated with drugs allergy (such as contrast, sirolimus, or structure-related compounds fluorinated polymers, thienopyridine or aspirin);
- •Subjects with active peptic ulcer, active gastrointestinal (GI) bleeding or other bleeding diathesis or coagulopathy;
- •Subjects being suffered from other serious illness (such as cancer, congestive heart failure), which may cause drop in life expectancy to less than 12 months;
- •Pregnant or breastfeeding women;
- •Refused this trial;
- •Subjects with severe liver or renal dysfunction (ALT >5×ULN，eGFR< 30ml/min/1.73mm2 or Scr>200 mmol/L);
- •Active bleeding;
- •Bleeding diathesis or coagulopathy, malignant tumors;
- •Contraindication of anticoagulant drugs;
- •Subjects with other situation not suitable for the study.
研究组 & 干预措施
OCT group
Patients, whose coronary chronic total occlusion lesion was successfully implanted stent, received optical coherence tomography imaging immediately and at 9-12 months after index procedure.
干预措施: OCT (Procedure)
结局指标
主要结局
long-term stent thrombosis
时间窗: 9-12 month after index procedure
measured through OCT imaging result
long-term minimal stent area
时间窗: 9-12 month after index procedure
measured through OCT imaging result
long-term stent malapposition
时间窗: 9-12 month after index procedure
measured through OCT imaging result
immediately stent malapposition
时间窗: in the procedure
measured through OCT imaging result
long-term stent neointima
时间窗: 9-12 month after index procedure
measured through OCT imaging result
immediately minimal stent area
时间窗: in the procedure
measured through OCT imaging result
次要结局
- Major Adverse Cardiovascular Events(9-12 month after index procedure)