BuMA OCT Study(A Comparative Evaluation of BuMA Stent and of EXCEL Stent in Terms of the Extent of Neointima Formation at 3 Months After Implantation Using OCT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- the percentage of the struts'neointimal coverage (%) at 3 months follow-up by OCT assessment.
研究概览
简要总结
The objective of this study is a comparative evaluation of BuMA stent and of EXCEL stent in terms of the extent of neointima formation at 3 months after implantation using OCT.
This is a prospective, single center, randomized, open-label, non-inferiority study, which will enroll a total of 70 patients in Fuwai Hospital.All patients will be randomly assigned undergoing implantation of BuMA stent or EXCEL stent (in a 1:1 ratio). If non-inferiority was met, superiority test will be planned.
详细描述
About 70 patients with clinical evidence of ischemic heart disease and / or a positive functional study and documented stable angina pectoris (Canadian cardiovascular society classification (CCS)1, 2, 3 or 4), or documented silent ischemia in de-novo, native, previously unstented vessel in Fuwai Hospital,will be randomly assigned undergoing implantation of BuMA stent or EXCEL stent (in a 1:1 ratio).
All of the patients will receive 6 months dual antiplatelet therapy and they will be followed (at the outpatient clinic) for up to 2 years. The follow-up visits will be conducted at 3 months (including angiographic/OCT investigation), 6 months, 1 and 2 years post percutaneous coronary intervention(PCI),in order to observe the Primary Endpoint and Secondary Endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 85 years.
- •Evidence of myocardial ischemia without raised troponin (e.g. stable or unstable angina, silent ischemia demonstrated by positive territorial functional study).
- •The patient has a planned intervention of up to four de novo lesions, in different epicardial vessels.
- •Lesion(s) must have a visually estimated diameter stenosis of ≥50% and <100%.
- •Reference Vessel Diameter(RVD) must be between 2.5-4.0 mm
- •Written informed consent.
- •The patient and the patient's physician agree to the follow-up visits including angiographic follow-up and OCT controls at 3 months.
排除标准
- •Evidence of ongoing acute myocardial infarction in ECG prior to procedure.
- •Left ventricular ejection fraction(LVEF) <30%.
- •Documented or suspected liver disease (including laboratory evidence of hepatitis).
- •Known renal insufficiency (e.g. estimated glomerular filtration rate(eGFR) <60 ml/kg/m2 or serum creatinine level of >2.5 mg/dL, or subject on dialysis).
- •History of bleeding diathesis or coagulopathy.
- •The patient is a recipient of a heart transplant.
- •Known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel and ticlopidine), sirolimus or stainless steel.
- •Other medical illness (e.g. cancer, neurological deficiency) or known history of substance abuse (alcohol etc.) as per physician judgment that may cause non-compliance with the protocol or confound the data interpretation or is associated with a limited life expectancy.
- •Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
- •OCT exclusion criteria
- •Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in suboptimal imaging or excessive risk of complication from placement of an OCT catheter
- •Total occlusion or thrombolysis in myocardial infarction(TIMI) flow 0, prior to wire crossing.
研究组 & 干预措施
BuMA stent
This study will enroll a total of 70 patients in Fuwai Hospital.All patients will be randomly assigned two groups(in a 1:1 ratio).
BuMA stent Arm:About 35 patients will undergoing implantation of BuMA stent.All of the patients will receive 6 months dual antiplatelet therapy and they will be followed (at the outpatient clinic) for up to 2 years. The follow-up visits will be conducted at 3 months(including angiographic/OCT investigation), 6 months, 1 and 2 years post PCI,in order to observe the Primary Endpoint and Secondary Endpoints.
干预措施: BuMA stent (Device)
EXCEL stent
This study will enroll a total of 70 patients in Fuwai Hospital.All patients will be randomly assigned two groups(in a 1:1 ratio).
EXCEL stent Arm:About 35 patients will undergoing implantation of EXCEL stent.All of the patients will receive 6 months dual antiplatelet therapy and they will be followed (at the outpatient clinic) for up to 2 years. The follow-up visits will be conducted at 3 months(including angiographic/OCT investigation), 6 months, 1 and 2 years post PCI,in order to observe the Primary Endpoint and Secondary Endpoints.
干预措施: EXCEL stent (Device)
结局指标
主要结局
the percentage of the struts'neointimal coverage (%) at 3 months follow-up by OCT assessment.
时间窗: three months after surgery
The primary outcome measure is the percentage of the struts'neointimal coverage (%) at 3 months follow-up by OCT assessment.
次要结局
- Neointimal hyperplasia area/volume(three months after surgery)
- Mean/Minimal Lumen diameter/area/volume(three months after surgery)
- Device-oriented Composite Endpoints and its individual components at 3 months(three months after surgery)
- Stent thrombosis according to the ARC definitions at 6 months(six months after surgery)
- Stent thrombosis according to the ARC definitions at 2 years(2 years after surgery)
- Binary Restenosis (DS ≥50%) at 3 months(three months after surgery)
- Device-oriented Composite Endpoints and its individual components at 6 months(six months after surgery)
- Mean/Minimal Stent diameter/area/volume(three months after surgery)
- Minimal Lumen Diameter(MLD) and Diameter stenosis percentage(%DS) post procedure and at 3 months(three months after surgery)
- Device-oriented Composite Endpoints and its individual components at 1 year(one year after surgery)
- Stent thrombosis according to the ARC definitions at 3 months(three months after surgery)
- Stent thrombosis according to the ARC definitions at 1 year(one year after surgery)
- Mean/maximal thickness of the struts coverage(three months after surgery)
- Incomplete strut apposition(three months after surgery)
- Late Lumen Loss at 3 months(three months after surgery)
- Acute success rate(up to 7 days after surgery)
- Device-oriented Composite Endpoints and its individual components at 2 years(2 years after surgery)