Multicenter Comparison of Early and Late Vascular Responses to Everolimus-eluting Cobalt-CHromium Stent and Platelet AggregatioN Studies In Patients With Stable Angina Managed as Elective Case : MECHANISM-Elective
试验速览
- 阶段
- 不适用
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Rate of stent-strut coverage determined by OCT.
研究概览
简要总结
To treat patients with stable coronary artery disease, elective percutaneous coronary intervention (PCI) will be performed with the use of an everolimus-eluting cobalt- chromium stent (everolimus-eluting stent: EES, Xience Prime, Xpedition), which is the current standard drug-eluting stent (DES). Vascular responses at the site of stent placement will be evaluated by optical coherence tomography (OCT) at 1 or 3 months and at 12 months after stent placement, along with observation of changes over time in the target vessel. The relationships between OCT findings and the time course of platelet aggregation and between OCT findings and the occurrence of major cardio- cerebrovascular events will also be elucidated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
All patients' information will be blinded to OCT image analyzers.
入排标准
- 年龄范围
- 20 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients having at least one de novo lesion in a coronary artery in whom PCI with a DES is indicated
- •Patients aged 20 to less than 85 years at the time of informed consent
- •Patients who have provided informed consent written by themselves
- •Patients who are able to undergo OCT examinations of the site of stent placement at 1 or 3 months and at 12 months
排除标准
- •If it is judged difficult to perform clinical and angiographic follow-up at 12 months (considering the patient's remote place of residence, etc.)
- •Patients with acute myocardial infarction (AMI)
- •Patients in a state of shock
- •Patients with cardiac failure
- •Patients having a culprit lesion in the left main coronary artery trunk
- •Patients having a lesion with a reference vessel diameter of less than 2.0 mm or 4.5 mm or larger by visual estimate
- •Patients having an in-stent restenosis lesion as the culprit lesion
- •Patients having chronic renal failure with a serum creatinine level of 2.0 mg/dL or higher at a screening visit
- •Patients on hemodialysis
- •Cancer patients with a life expectancy of less than 2 years
- •Patients who are scheduled to undergo elective surgery requiring discontinuation of antiplatelet therapy within the next 3 months
- •Pregnant women or women expected to become pregnant
- •Patients with a history of adverse reactions to aspirin or clopidogrel (however, it is acceptable to enroll patients in whom the safety of ticlopidine has been confirmed, even if they have a history of adverse reactions to clopidogrel)
研究组 & 干预措施
3 month OCT follow-up, CoCr-EES
Elective PCI can be performed with the use of an EES. PCI in another vessel or follow-up angiography is expected to be performed 3 months after the index procedure.
干预措施: CoCr-EES (Device)
1 month OCT follow-up, CoCr-EES
Elective PCI can be performed with the use of an EES. PCI in another vessel or follow-up angiography is expected to be performed 1 months after the index procedure.
干预措施: CoCr-EES (Device)
结局指标
主要结局
Rate of stent-strut coverage determined by OCT.
时间窗: 3 months
Rate of stent-strut coverage determined by OCT at 3 months after stent placement (To observe temporal course from the early stage, the rate of stent-strut coverage in the 1-month arm will also be evaluated in a complementary manner, separately from the 3-month arm.) To identify the factors defining the strut coverage at 1-month or 3-months, from OCT index, blood markers, platelet aggregation test immediately after stenting, the strut coverage of 1 to 3 months
次要结局
- Any TLR(1-year)
- CABG(1 year)
- Any revascularization(1 year)
- Clinically-driven TLR(1 year)
- Angiographic binary restenosis(12 month)
- The percentage of stent strut coverage by OCT(12 month)
- Angiographic Quantitative analysis(12 month)
- All-cause Death, Cardiac death, MI, Stroke, Major bleeding(1-year)
- Any TVR(1 year)
- Patient-oriented composite(1 year)
- OCT endpoint(1-month or 3-month)
- Angiographic Qualitative analysis(12 month)
研究者
Toshiro Shinke, MD, PhD
Associate Professor
Kobe University