A Prospective, Multicenter Trial Program in China to Evaluate the Efficacy and Safety of BuMA Supreme (eG Grafting) Biodegradable Polymer Sirolimus Eluting Stent in Patients With de Novo Coronary Lesions, OPC Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Target Lesion Failure
研究概览
简要总结
PIONEER-II OPC trial is a prospective, multicenter, single-arm registry trial. 1000 subjects from approximately 40 interventional cardiology centers will be enrolled to evaluate the target lesion failure(TLF) as the primary endpoint at 1 year. And all the subjects will be followed up to 5 years to attain the data of the secondary endpoints.
详细描述
Realizing even more uniform and complete endothelial coverage, BuMA Supreme™ biodegradable drug coating coronary stent system comprises a new generation of biodegradable drug eluting stent under development by Sino medical science(SINOMED). BuMA Supreme™ reconfigures BuMA™ DES utilizing a high caliber cobalt chromium platform coated with rapidly degrading PLGA scaffold.
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 non-pregnant female
- •Evidence of non-symptomatic ischemia, stable or non-stable angina pectoris or past MI
- •Target lesion is primary and de-novo coronary artery disease
- •The target lesion length ≤ 60 mm, diameter 2.25mm-5.0mm (visually estimated)
- •Lesion diameter stenosis ≥70% (visually estimated)
- •For each target lesion, same stent implantation only
- •Acceptable candidate for Coronary Artery Bypass Grafting(CABG)
- •Understand the study purpose, willing to participate and sign the letter of consent, agrees to the follow-up visits including a 9 month angiographic follow-up
排除标准
- •Acute MI within 1 week
- •Chronic total occlusion(TIMI 0), left main lesion, intervention-required three-vessel lesions, branch vessel diameter ≥ 2.5mm and bypass lesion
- •More than 3 stents required
- •Patients refuse to be implanted stent
- •Calcified lesion failed in pre-dilation, twisted lesion and lesion unsuitable for stent delivery and expansion
- •In-stent restenosis
- •Planned percutaneous coronary intervention (PCI) within 3 months post procedure
- •Other stents implanted within 1 year
- •Severe heart failure (NYHA above III) or left ventricle ejection fraction(EF) <40%
- •Renal function damage, blood creatinine > 176.82 μmol/L
- •Bleeding tendency, active peptic ulcer disease, cerebral or subarachnoid hemorrhage, cerebral apoplexy within half year and contraindication for any anti-platelet or anticoagulation agents
- •Allergic to drugs or agents used in stent or protocol (PLGA, sirolimus, aspirin, clopidogrel, contrast agent, cobalt, nickel, chromium, iron, wolfram et. al.)
- •Life expectation < 12 months
- •Have not reached the primary end point when participating in other trial
- •Poor compliance to the protocol
- •Heart implantation cases
结局指标
主要结局
Target Lesion Failure
时间窗: 1 year
Target Lesion Failure(TLF) is defined as cardiac death, target vessel myocardial infarction(MI), or clinically-driven target lesion revascularization (TLR).
次要结局
- Device-oriented Composite Endpoint(DoCE)(1, 6, 12 month, and annually up to 5 years post procedure)
- Stent implantation success rate(5 years after PCI)
- Academic Research Consortium(ARC) defined stent thrombosis(5 years after PCI)
- Patient-oriented Composite Endpoint (PoCE)(1, 6, 12 month, and annually up to 5 years post procedure)