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
- Conditions
- Coronary Artery Disease
- Registration Number
- JPRN-UMIN000012616
- Lead Sponsor
- Kobe University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 100
Not provided
1 If it is judged difficult to perform clinical and angiographic follow-up at 12 months (considering the patient's remote place of residence, etc.) 2 Patients with acute myocardial infarction (AMI) 3 Patients in a state of shock 4 Patients with cardiac failure 5 Patients having a culprit lesion in the left main coronary artery trunk 6 Patients having a lesion with a reference vessel diameter of less than 2.0 mm or 4.5 mm or larger by visual estimate 7 Patients having an in-stent restenosis lesion as the culprit lesion 8 Patients having chronic renal failure with a serum creatinine level of 2.0 mg/dL or higher at a screening visit 9 Patients on hemodialysis 10 Cancer patients with a life expectancy of less than 2 years 11 Patients who are scheduled to undergo elective surgery requiring discontinuation of antiplatelet therapy within the next 3 months 12 Pregnant women or women expected to become pregnant 13 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)
Study & Design
- Study Type
- Interventional,observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method