Characteristics of Intimal and Neoatherosclerosis in Patients With Restenosis After DES Implantation for Calcified Lesions
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Mean lumen area
研究概览
简要总结
Previous studies have suggested that restenosis (RS) after stenting is mainly due to smooth muscle cell proliferation and migration, but recent evidence suggests that in-stent restenosis（ISR） is associated with a number of factors. Coronary artery calcification is an independent predictor of ischaemia-mediated revascularisation 1 year after percutaneous coronary intervention (PCI) following RS.The characteristics of new neointima in patients with in-stent restenosis of calcified lesions are important issues to explore
详细描述
The characteristics of the endothelium after DES following implantation of calcified lesions have always been of interest to us. Its inherent peculiarities make the new endothelium of calcified lesions different.
Firstly, the presence of calcification makes the neointima heal slowly. In addition DES has an anti-proliferative effect, which further diminishes the healing ability of the neointima of calcified lesions and impairs the barrier function of the endothelium. This may have a similar pathway to the formation of neointimal atherosclerosis or heterogeneous endothelium within the neointima.
Secondly, stents with calcified lesions can be accompanied by incomplete stent expansion, stent fracture and stent misalignment. These conditions may accelerate the occurrence of restenosis within the stent.
Thirdly, there are different types of calcified lesions. Different types of calcified lesions may heal and restenosis in different ways.
It is therefore understood that calcified lesion healing has a number of pathways that exist in contradiction. These are issues that need to be explored in depth.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •The patient is older than 18 years.
- •The patient had undergone coronary angiography at our hospital for PCI and had first ISR with drug-eluting stent implantation.
- •Calcified lesion greater than 5 mm in length.
- •Stent implantation time greater than 30 days.
排除标准
- •Bridge vessel lesions following coronary artery bypass grafting.
- •Planned modification of the DAPT regimen for medical reasons or other surgical procedures requiring modification within 3 months of the index procedure.
- •Patients undergoing heart transplantation.
- •Significant angiogenic lesions in the target vessel that may prevent stent delivery and deployment.
- •Bifurcation disease lesions involving collateral branches ≥ 2.5 mm in diameter.
- •Lesions deemed by the investigator to be unsuitable for OCT imaging (e.g., extremely curved, very distal lesions).
- •Serum creatinine > 2.0 mg/dl at the time of treatment.
- •Greater than three types of stent implantation.
- •Subjects with malignancy or other co-morbidities (i.e., severe liver, kidney, lung, or pancreatic disease with a life expectancy of less than 18 months or which may result in protocol non-compliance).
结局指标
主要结局
Mean lumen area
时间窗: through study completion, an average of 1 year
Quantitative Indicators，the mean area bounded by the luminal border on OCT（Optical Coherence Tomography）
stent fracture
时间窗: through study completion, an average of 1 year
Qualitative indicators,the interruption of stent continuity.the investigators measured its incidence on OCT.
Intimal rupture
时间窗: through study completion, an average of 1 year
Qualitative indicators,discontinuity of the fibrous cap connecting the lumen.the investigators measured its incidence on OCT.
Percent area stenosis
时间窗: through study completion, an average of 1 year
Quantitative Indicators，the (reference lumen area minus the minimum lumen area) divided by the reference lumen area, multiplied by 100. The reference segment used should be specified (proximal, distal, largest or average) on OCT
Mean stent area
时间窗: through study completion, an average of 1 year
Quantitative Indicators，the mean area bounded by the stent border on OCT
Minimum stent area
时间窗: through study completion, an average of 1 year
Quantitative Indicators，the Minimum area bounded by the stent border on OCT
Thrombi
时间窗: through study completion, an average of 1 year
Qualitative indicators,masses protruding into the lumen and discontinuous from the surface of the vessel wall.the investigators measured its incidence on OCT.
Uncovered struts
时间窗: through study completion, an average of 1 year
the ratio of uncovered-to-total stent struts per section was calculated and expressed as percent on OCT.
neoatherosclerosis
时间窗: through study completion, an average of 1 year
neoatherosclerosis were defined by the presence of one or more of the following: lipid laden tissue ，thin-cap fibroatheroma (TCFA)，neointimal calcification，Macrophage infiltration.the investigators measured its incidence .
Minimum lumen area
时间窗: through study completion, an average of 1 year
Quantitative Indicators，the minimum area bounded by the luminal border on OCT
Maximum lumen area
时间窗: through study completion, an average of 1 year
Quantitative Indicators，the maximum area bounded by the luminal border on OCT
Maximum stent area
时间窗: through study completion, an average of 1 year
Quantitative Indicators，the Maximum area bounded by the stent border on OCT
lipid-laden intima
时间窗: through study completion, an average of 1 year
Qualitative indicators,a diffusely bordered, signal-poor region with overlying signal-rich bands in the intima on OCT.the investigators measured its incidence on OCT.
Calcification
时间窗: through study completion, an average of 1 year
Qualitative indicators,shows a well-delineated, signal-poor region with sharp borders.the investigators measured its incidence on OCT.
Neovascularization
时间窗: through study completion, an average of 1 year
Qualitative indicators,the presence of signal-poor holes or tubular structures with a diameter of 50 to 300 μm that are not connected to the vessel lumen.the investigators measured its incidence on OCT.
Thin-cap fibroatheroma (TCFA)
时间窗: through study completion, an average of 1 year
containing intima was defined as fibrous cap thickness ≤65 μm at the thinnest segment and an angle of lipid tissue ≥180°.the investigators measured its incidence on OCT.
Macrophage infiltration
时间窗: through study completion, an average of 1 year
Qualitative indicators,a bright spot with a high signal variance from the surrounding tissue.the investigators measured its incidence on OCT.
Stent underexpansion
时间窗: through study completion, an average of 1 year
Qualitative indicators,Stent expansion describes the minimum stent cross-sectional area either as an absolute measure (absolute expansion), or compared with the predefined reference area, which can be the proximal, distal, largest, or average reference area (relative expansion).the investigators measured its incidence on OCT.
次要结局
未报告次要终点
研究者
Zhen Fang
clinical doctor
Shenyang Northern Hospital