A Prospective Multicenter Single-Arm Observational Registry Study Assessing the Safety and Efficacy of FIREHAWK Biodegradable Polymer Target-release Rapamycin-eluting Stent for the Treatment of Coronary Artery Disease: TARGET II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 730
- 试验地点
- 1
- 主要终点
- TLF (Target Lesion Failure) Rate
研究概览
简要总结
The study aims to further assess the safety, efficacy and the performance of its delivery system of FIREHAWK rapamycin-eluting stent up to five years.
详细描述
This is a prospective open-labeled, multi-center, single-arm observational registry study. Approximately 1,100 subjects will be enrolled to evaluate the TLF as the primary endpoint at 12-month. Also, the study will follow up those subjects up to 5 years as the secondary endpoints.
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
- •Age 18-75, male or unpregnant women
- •Evidence of non-symptomatic ischemia, stable or non-stable angina or past MI
- •Native coronary artery target lesion
- •Target lesion length <=60mm, target lesion vessel diameter 2.25mm-4.0mm
- •Target lesion diameter stenosis>=70%
- •For each target lesion, Firehawk stent implantation only
- •Understand the study purpose, willing to participate and sign the letter of consent
- •Acceptance of clinical follow-up
排除标准
- •Acute MI within 72 hours
- •Unprotected LM and intervention-required three-vessel lesions
- •Calcified lesion failed in pre-dilation and twisted lesion
- •Bridge vessel lesion
- •Any stent implanted within one year
- •Severe heart failure (HYHA>=III) or LVEF<40%
- •Renal deficiency, blood creatinine > 2.0mg/dl
- •Bleeding tendency
- •Allergic to aspirin, clopidogrel, ticlopidine, dye, rapamycin and metal
- •Life expectation <12 months
- •History of not achieving study finish
- •No compliances to the protocol
- •Heart implantation subjects
研究组 & 干预措施
Firehawk
Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD
干预措施: FIREHAWK biodegradable polymer rapamycin-eluting stent (Device)
结局指标
主要结局
TLF (Target Lesion Failure) Rate
时间窗: 12 months after index procedure
Percentage of participants with determination of TLF ,TLF is the composite of cardiac death, target vessel MI and clinically driven TLR
次要结局
- Stent Implantation Success Rate (SIS Rate)(immediately after the procedure)
- TLF (Target Lesion Failure)(5 years after index PCI)
- Patient-related Cardiovascular Clinical Composite Endpoints(5 years after index PCI)