Firebird2 Cobalt-Chromium Alloyed Sirolimus-Eluting Stent Registry Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- rate of major adverse cardiac events
研究概览
简要总结
The experimental design is a multi-center, prospective, non-controlled, non-randomized, single-arm clinical registry trial. The study will enroll 5,000 patients who receive the Firebird2TM Cobalt-ChromiumAlloyed Sirolimus-Eluting Stent implantation. For patient with multivessel disease, only Firebird 2TM Stent will be implanted. The enrollment of patients will take about 4 months. Clinical follow-up will be at 30 day, 6 month, 12 month, 24 month and 36 month. Patients withdrawing the study due to any reasons will not be replaced.
详细描述
[Definition and management of adverse event] Adverse event refers to any undesirable clinical event. It may be caused by devices, rapamycin, procedure related complications, or the adjunctive medications (such as aspirin, clopidogrel, ticlopidine, or other anti-platelet agent) used in this study. Self report of adverse events by patients should be encouraged. Patients have a right to inquire any information on adverse event at any time of the study. If an adverse event is confirmed, the investigator should collect all related information and complete the Adverse Event Form.
[Classification of adverse events severity] Mild: Mild adverse event refers to clinical event not interfering patient's daily activities.
Moderate: Moderate adverse event refers to clinical event affecting patient's daily activities.
Serious: Serious adverse event refers to clinical event results in patient's inability to undertake daily activity.
[Management of adverse event] All adverse events occurring during the study period should be documented on Adverse Event Forms. Investigators should provide appropriate treatment for all adverse events and follow up the patient until symptom(s) disappear or remain stable
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Age≧18 years
- •Patient being suitable candidate for the implantation of drug-eluting stent at physician's discretion
- •Patient with multivessel disease who receive only Firebird2 Stent
- •Patient agrees to provide informed consent to follow the clinical trial protocol, including medications, and baseline and follow-up visits and procedures.
排除标准
- •Patient not being suitable candidate for the implantation of drug-eluting stent at physician's discretion
- •Patient with multivessel disease who receive other type of stents instead of only Firebird2 Stent
- •Patient who receive other PCI interventions, such as rotablation, directional coronary atherectomy (DCA), TEC, CRA, laser angioplasty, etc.), in addition to PTCA and stenting
- •Patient refuses to provide informed consent
- •Patient who are not able to follow the clinical trial protocol, including medications, and baseline and follow-up visits and procedures
结局指标
主要结局
rate of major adverse cardiac events
时间窗: 12 months
次要结局
未报告次要终点