INCSTENT First-in-Man Study: Safety and Efficacy of INC-1 Bare Metal Stent in the Novo Coronary Lesions.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Incidence of late lumen loss [Safety and Tolerability])
研究概览
简要总结
This is a First In Man study with the aim to know the safety and effectiveness of a novel bare metal stent (INC-1) in the treatment of de novo coronary lesions in patients with stable coronary angina and unique coronary lessions.
详细描述
The cost of performing a percutaneous coronary intervention is very variable since a large number of materials and human resources are considered, with the Stent cost being a fundamental factor; in developing countries, the cost this technology represents an important expense for the patient and the health system; which promotes the development of local technology to support the requirement of these devices.
Ischemic heart disease together with cerebral vascular events is the main cause of, adding 15 million deaths per year. Percutaneous revascularization is the gold standard choice in many of the variants of presentation of ischemic heart disease, the implantation of Stents is the most used method.
Nowadays more and more countries start their own research and development of novel devices in order to reduce cost.
Research question: Is the INC1 Bare Metal Stent safe and effective for the treatment of de novo coronary lesions in humans? Hypothesis: The INC1 Bare-metal Stent is safe and effective for the treatment of de novo coronary lesions in humans
The INC1 Bare metal Stent is a 70uCoCr
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders.
- •From 18 to 75 years
- •Stable ischemic heart disease.
- •Live less than 300 km from the Institution
- •Single coronary artery disease with a single coronary lesion
- •Stenosis of 50 to 90% of the lumen of the vessel to be treated.
- •Lesions less than 20 mm long
- •Reference lumen of the vessel to be treated greater than 2.5mm and less than 4.5mm
排除标准
- •Left main disease.
- •Lesions greater than 90% of the lumen.
- •Non-dilatable lesion with conventional balloons.
- •Contraindication for dual antiplatelet therapy.
- •Creatinine clearance less than 45ml / min.
- •Calcification from moderate to severe.
- •Multivessel coronary artery disease.
- •Chronic total occlusion.
- •Cardiogenic shock or hemodynamic instability.
- •Left ventricular ejection fraction less than 30%.
- •Valvular disease of moderate to severe.
- •Coronary disease in bifurcation.
- •Probable or definite presence of thrombus in the lesion.
结局指标
主要结局
Incidence of late lumen loss [Safety and Tolerability])
时间窗: 9 months
The primary endpoint of the study is angiographic in-stent late lumen loss (LLL), defined as the difference between the post-procedural minimal lumen diameter (MLD) in the stented segment and the MLD in the same segment at follow-up measured by the angiography laboratory.
次要结局
- Hyperplasia(9 months)
- MACE(9 months)
- Need of Revascularization(9 months)
研究者
Gian Manuel Jiménez Rodríguez
Clinical investigator assistant
Instituto Nacional de Cardiologia Ignacio Chavez