A Prospective Multi-center Randomized Trial Assessing the Safety and Effectiveness of Biodegradable Polymer Target Release Rapamycin-Eluting STent vs. XIENCE V Everolimus-Eluting Stent for the Treatment of Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 458
- 试验地点
- 2
- 主要终点
- 9 Months In-stent Late Lumen Loss
研究概览
简要总结
The purpose of this study is to evaluate new generation drug eluting stent (DES) of MicroPort of its safety, efficacy and delivery system in treating CAD.
详细描述
The primary endpoint is in-stent late lumen loss after 9 months of the stent implantation. The secondary endpoint is in-stent percent diameter stenosis.This study is based on non-inferior assumption (vs. Xience V), requiring both endpoints reach statistical significance. Prespecified OCT follow-up is planned at 3-Year after index procedure at 3 chosen hospitals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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 women who are not pregnant
- •Evidence of non-symptomatic ischemia, stable or non-stable angina or past heart attack cases
- •Target lesion is primary, single artery and single lesion of coronary artery
- •Target lesion vessel length ≤24mm, diameter 2.25mm-4.0mm
- •Lesion diameter stenosis ≥70%
- •Candidates understand the study, willing to sign Consent of Agreement and to willing to accept follow-up For long lesion group, at least one target lesion length ≥28mm，diameter 2.5mm-4.0mm, and one lesion needs to implant 33mm 0r 38mm long stent
排除标准
- •Acute heart attack within one week
- •Chronic complete stenosis (TIMI 0), left main lesion, three branches need to treat, branch vessel diameter ≤2.5mm and bypass lesion
- •Calcified lesion failed in pre-dilation and twisted lesion
- •In-stent restenosis
- •Stent implanted within one year
- •Severe heart failure (NYHA above III) or left ventricle EF <40%
- •Renal function damage, blood creatinine >2.0mg/dl
- •Bleeding risk; allergic to drugs and agents used in procedure/treatment
- •Life expectation < 12 months
- •No compliances to the protocol
- •Heart implantation cases
- •Pre-specified OCT inclusion/exclusion criteria:
- •Patients underwent 9-month angio F/U
- •No binary restenosis at 9-month
- •LLL between -0.01~0.2mm
- •No mix-implanted stent
- •No more than one bail-out stent
- •No TLR occurred at 3 years after PCI
- •The target vessel able to deliver the OCT catheter
研究组 & 干预措施
Xience V
Implantation of Xience V drug eluting stent
干预措施: Xience V (Device)
Firehawk
Implantation of Firehawk drug eluting stent
干预措施: Firehawk (Device)
结局指标
主要结局
9 Months In-stent Late Lumen Loss
时间窗: 9 months
To observe in-stent late lumen loss after 9 months of stent implantation It means the difference between the minimal lumen diameter immediately after stent implantation and the minimal lumen diameter by angiography review 9 months after the procedure
次要结局
- 9 Months In-stent Diameter Stenosis(9 months)
- Target Lesion Failure(TLF) Rate(1 years after index PCI)
- Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)(5 years after index PCI)
- TLF(Target Lumen Failure) Rate(3 years after index PCI (Percutaneous Coronary Intervention))
- TLF(Target Lumen Failure)(5 years after index PCI)