NCT06631755招募中不适用
Influence of Vessel Wall Calcification on Early Stent Strut Healing (CaOCT Study)
Fundación EPIC2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年11月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Mean strut coverage thickness of stent
研究概览
简要总结
To assess the influence of superficial calcium on the early endothelialization (1 month) of the struts of the Xience Skypoint stent (comparing struts with underlying superficial calcium to struts without underlying calcification)
详细描述
To assess the influence of superficial calcium on the early endothelialization (1 month) of the struts of the Xience Skypoint stent (comparing struts with underlying superficial calcium to struts without underlying calcificatition by opticaL COHERENCE TOMOGRAPHY.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet all the following conditions will be included:
- •Patients aged ≥ 18 years old and;
- •Patients with clinical indication for stent implantation and;
- •Patients with OCT evaluation that shows the presence of calcified tissue underlying the lumen surface, fulfilling the definition of superficial calcium (The distance from the abluminal point of the calcium to the luminal surface is less than 500 μm, in a perpendicular axis to the vessel luminal surface. When referred to the stent struts it will be assumed that such distance of less than 500 μm will be measured between the centre of the abluminal surface of the strut and the abluminal point of the calcium, in the same perpendicular axis).and;
- •Patients with good quality baseline OCT evaluation as judged by the investigators and;
- •Patients who have been briefed on the study characteristics and have given their prior written informed consent.
排除标准
- •Patients who meet, at least, 1 of the following conditions will be excluded:
- •Patients with current ST-elevation Myocardial Infarction (STEMI).
- •Patients with non-native lesion: stent restenosis, segment previously treated with drug eluting balloon, arterial or saphenous vein grafts.
- •Patients with contraindication for the 1-month follow-up angiography and OCT:
- •Glomerular Filtration Rate (GFR)< 30 ml/min/1.72m2
- •Contrast allergy
- •Baseline post-stent control OCT failure, due to tortuosity or any other reason.
- •Patient not candidate for a follow up angiography, due to frailty, non-cardiac disease or whatever other condition considered by the local team.
结局指标
主要结局
Mean strut coverage thickness of stent
时间窗: 1 month
Mean strut coverage thickness (μ) of the stent struts located over superficial calcium will be compared to the mean strut coverage thickness of the struts in the calcium free frames by Optical Coherence Tomography (OCT).
次要结局
- Proportion of covered struts(1 month)
- Proportion of uncovered struts(1 month)
- Proportion of acute post PCI malapposition struts(1 month)
- Proportion of malapposed struts(1 month)
- Proportion of the resolution of the baseline malapposition struts(1 month)
- Degree of endothelialization(1 month)
- Major adverse cardiovascular events (MACE)(6 months)
- All Death(6 months)
- Cardiac Death(6 months)
- Myocardial Infarction(6 months)
- Target Vessel Revascularization(6 months)
研究者
研究点 (2)
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