PK(Pharmacokinetic) Papyrus Covered Coronary Stent System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Determining the number of the unanticipated adverse events related to the use of PK Papyrus Coronary Stent Graft System
研究概览
简要总结
The PK Papyrus Covered Coronary Stent System is a coronary stent being used at Methodist Dallas Medical Center for patients with coronary perforations.
详细描述
The FDA has approved the PK Papyrus Covered Coronary Stent System for use in patients being treated for acute perforations of native coronary arteries and coronary bypass grafts in vessels ranging from 2.5 to 5.0 mm in diameter, under a Humanitarian Device Exemption (HDE #H170004). Methodist Dallas Medical Center will use this device for treating the above-described patient population.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter
排除标准
- •Patients in whom antiplatelet agents or anticoagulation therapy is contraindicated.
- •Patients with a known allergy or hypersensitivity to amorphous silicon carbide or any other compound of the system (siloxane-based polyurethane, L-605 cobalt chromium alloy including tungsten and nickel).
- •Lesions that cannot be reached or treated with the system.
- •Lesions with threatened or abrupt closure during attempted pre-dilation prior to stent implantation.
- •Risk of treatment-related occlusion of vital coronary artery side branches.
- •Uncorrected bleeding disorders.
- •Allergy to contrast media.
研究组 & 干预措施
PK Papyrus Covered Coronary Stent System
PK Papyrus Covered Coronary Stent System has been approved for use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts greater than or equal to 2.75mm in diameter.
干预措施: PK Papyrus Covered Coronary Stent System (Device)
结局指标
主要结局
Determining the number of the unanticipated adverse events related to the use of PK Papyrus Coronary Stent Graft System
时间窗: Up to 10 years
Number of patients with PK Papyrus being treated for acute perforations of native coronary arteries and bypass grafts in vessels.
Number of patients with the device
时间窗: 10 years
number of patients with success coronary artery and bypass grafts
次要结局
未报告次要终点