NCT02319733终止不适用
Plaque Stabilization and Restoration of Vascular Function by Bioresorbable Vascular Scaffold in Acute Coronary Syndrome Prone Patients
Canisius-Wilhelmina Hospital2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2014年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- change in plaque cumulative score of signs of vulnerability on CT
研究概览
简要总结
The aim of the study is to assess if implantation of a bioresorbable vascular scaffold (BVS) for intermediate coronary lesions with morphological signs of vulnerable plaque in patients prone for acute coronary syndromes (ACS) will stabilize the plaque, improve natural vasomotion and increase vascular diameter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic patients between the age of 18 and 80 years
- •Morise Risk score of ≥9 (intermediate or high risk) but no proven ischemia (no positive troponin or ST-elevation)
- •Intermediate coronary lesion on CT scan (50-70% based on CT estimate) and a plaque with at least two of the following vulnerability criteria: Napkin ring sign, positive remodeling, low attenuation and spotty calcification
- •FFR negative lesion at coronary angiogram
- •Vessel diameter ≥2.5 mm on visual estimate
- •GFR ≥ 45mL/min/1.73m².
排除标准
- •High calcium score on CT scan preventing adequate evaluation of the coronary lesion.
- •Lesions located in a coronary vessels previously stented.
- •Lesions located at a bifurcation
- •lesions involving an epicardial side branch ≥2 mm in diameter by visual assessment
- •the presence of thrombus or another clinically significant stenosis in the target vessel.
- •Left main (>50%) or known three vessel disease.
- •Patients presenting with acute myocardial infarction, unstable arrhythmias, or patients who have a left ventricular ejection fraction <30%
- •Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparine or Everolimus and known true anaphylaxis to prior contrast media or known bleeding diathesis or known coagulopathy.
- •Planned elective surgical procedure necessitating interruption of dual antiplatelet therapy during the first 6 months after inclusion.
- •History of stent thrombosis
- •Malignancies or other comorbidity with a life expectancy of less than one year or that may result in protocol noncompliance
- •Pregnancy (present, suspected or planned) or positive pregnancy test (in women with childbearing potential a negative pregnancy test is mandatory)
结局指标
主要结局
change in plaque cumulative score of signs of vulnerability on CT
时间窗: 24 months
nominal change in percent necrotic core and thin-cap fibroatheroma at VH-IVUS
时间窗: 24 months
次要结局
未报告次要终点
研究者
M.E.R. Gomes
dr.
Canisius-Wilhelmina Hospital
研究点 (2)
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