Relationship Between Initial Plaque Characteristics and Stent Surface Coverage Patterns After Sirolimus-eluting Stent Implantation Assessment by Optical Coherence Tomography
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To investigate the relationship between initial plaque characteristics and stent surface coverage after sirolimus-eluting stent implantation.
研究概览
简要总结
Vulnerable plaque characterized by thin fibrous cap and large lipid core is an independent risk factor for most of acute cardiac event. Current clinical data showed that thin-cap fibroatheroma was more frequently observed in patients with ACS than SAP. Further OCT study indicated that patients with ACS had significantly higher incidence of incomplete neointimal coverage and malapposition after DES implantation than those with SAP. These findings imply that initial native lesion characteristics may be related to different vessel response (neointimal coverage and malapposition) after stenting. However, there is little data on the relationship between plaque characteristics and vascular response to DES after stent implantation evaluated by OCT.
Therefore, this study was designed to investigate the relationship between initial plaque characteristics and stent surface coverage or late malapposition after SES implantation. The investigators will use high resolution OCT to assess the initial culprit plaque morphology and subsequent vascular response after SES stenting at the time points of post-stenting, 6 months and 12 months. IVUS will also be performed to evaluate the tissue protrusion, malapposition, vessel remodeling at the same time points.
详细描述
Vulnerable plaque characterized by thin fibrous cap and large lipid core is an independent risk factor for most of acute cardiac event. Current clinical data showed that thin-cap fibroatheroma was more frequently observed in patients with ACS than SAP. Further OCT study indicated that patients with ACS had significantly higher incidence of incomplete neointimal coverage and malapposition after DES implantation than those with SAP. These findings imply that initial native lesion characteristics may be related to different vessel response (neointimal coverage and malapposition) after stenting. However, there is little data on the relationship between plaque characteristics and vascular response to DES after stent implantation evaluated by OCT.
Therefore, this study was designed to investigate the relationship between initial plaque characteristics and stent surface coverage or late malapposition after SES implantation. The investigators will use high resolution OCT to assess the initial culprit plaque morphology and subsequent vascular response after SES stenting at the time points of post-stenting, 6 months and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General Inclusion Criteria：
- •Patients with stable angina or acute coronary syndrome considered suitable for coronary revascularization.
- •Patient or legal guardian understands and agrees to comply with all specified study requirements and provides written informed consent.
- •Angiographic Inclusion Criteria：
- •Significant coronary de novo lesion (> 70% by visual estimation).
- •Target lesion is de novo native coronary artery lesion that can be treated with 1-2 stents.
- •Reference vessel diameter of 2.5 to 4.0 mm.
排除标准
- •General Exclusion Criteria：
- •ST-segment elevation myocardial infarction within 7 days prior to the index procedure.
- •Previous CABG.
- •Life expectancy <12 months due to another medical condition.
- •Contraindication to antiplatelet therapy
- •Creatinine level more than 2.0mg/dL or ESRD.
- •Severe hepatic dysfunction (more than 3 times normal reference values).
- •Planned surgery procedure ≤ 6 months post-index procedure.
- •Known allergy to stainless steel or a history of hypersensitivity to sirolimus or structurally related compounds.
- •Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the 12 months post index procedure.
- •Patient is not clinically appropriate for OCT evaluation in the opinion of the investigator.
- •Angiographic Exclusion Criteria：
- •Study lesion is ostial in location (within 3.0 mm of vessel origin).
- •Study lesion involving arterial segments with highly tortuous anatomy.
- •Complex lesion morphologies (aorto-ostial, bifurcation needs two stents technique, left main, severe thrombi, heavy calcification).
结局指标
主要结局
To investigate the relationship between initial plaque characteristics and stent surface coverage after sirolimus-eluting stent implantation.
时间窗: 6 months
To investigate the relationship between initial plaque characteristics and stent surface coverage after sirolimus-eluting stent implantation.
次要结局
- Relationship between tissue prolapse and initial plaque characteristics(Post-intervention)
- Comparison of the differences in vascular response (surface coverage and malapposition) between CTO and non- CTO lesions.(6-month)
- Late stent malapposition( by OCT and IVUS ).(6 months)
- Relationship between initial lesion characteristics and stent surface coverage pattern after SES implantation.(12 -month)
- Comparison of the differences in stent surface coverage between CTO and non- CTO lesions.(12 months)
研究者
Yu Bo
Prof
Harbin Medical University