OPTIMIZE Sirolimus-Eluting Coronary Stent Systems Pharmacokinetics (PK) Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Time to reach maximum blood concentration (tmax)
研究概览
简要总结
To evaluate the pharmacokinetic parameters of sirolimus release from the Svelte DES.
详细描述
This is a prospective, open, non-randomized, study involving two (2) centers in the United States. A minimum of twelve (12) and a maximum of fifteen (15) subjects will be consented, treated and have blood samples drawn to evaluate the pharmacokinetic parameters of sirolimus release from the Svelte DES.
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
- •Subject is an eligible candidate for PCI
- •Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia
- •Subject is an acceptable candidate for CABG
- •Subject has ≤ 3 de novo target lesions in ≤ 2 native coronary artery vessels, with ≤ 2 lesions in a single vessel, each meeting the angiographic criteria and none of the exclusion criteria
- •Target lesion(s) must be located in a native coronary artery with RVD ≥ 2.25mm and ≤ 4.00mm
排除标准
- •Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmia, or ongoing intractable angina
- •Subject's target lesion(s) is located in the left main coronary artery
- •Subject's target lesion(s) is located within 3mm of the origin of the LAD or LCX coronary artery
- •Subject's target lesion(s) is located within a SVG or an arterial graft
- •Subject's target lesion(s) will be accessed via SVG or arterial graft
结局指标
主要结局
Time to reach maximum blood concentration (tmax)
时间窗: Up to 30 days
Apparent volume of distribution (Vd/F)
时间窗: Up to 30 days
Maximum observed blood concentration (Cmax)
时间窗: Up to 30 days
Area under the blood concentration versus time curve: time zero to the final quantifiable concentration) (AUC 0-t)
时间窗: Up to 30 days
Area under the blood concentration versus time curve: time zero to the extrapolated infinite time (AUC 0-∞)
时间窗: Up to 30 days
Terminal phase half-life (t1/2)
时间窗: Up to 30 days
Apparent total blood clearance (CL/F)
时间窗: Up to 30 days
次要结局
- Target Vessel Failure (TVF)(6 months, 12 months, 2 years)