Feasibility of CRE8 polymer-free Amphilimus-eluting sTEnt in patients with diffuse long lesions (CREATE trial ): Prospective, Observational study
Not Applicable
Recruiting
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0007362
- Lead Sponsor
- Yonsei University Yongin Severance Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
1. 19 years of age or older
2. Clinical evidence of coronary artery disease including asymptomatic ischemia, stable angina, and acute coronary syndrome (an unstable angina, non-ST segmental ascending myocardial infarction, ST segmental ascending myocardial infarction)
3. Coronary lesion length greater than 30 mm
4. Voluntary written consent to participate in this clinical study
Exclusion Criteria
1. Life expectancy within one year
2. Subjects with known intolerance or contraindications for the following drugs or substances: heparin, aspirin, clopidogrel, prashgrel, ticagreler
3. If other researchers decide that they are unsuitable for participation in this study (pregnant women, the elderly, etc.)
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of one-year target lesion failure (a combination of cardiac death, target vascular myocardial infarction, and ischemic-induced target lesion re-perfusion)
- Secondary Outcome Measures
Name Time Method One-year major cardiac adverse events (complex variables of death, myocardial infarction, stent thrombosis, and targeted lesion perfusion);a one-year incidence of heart death;1-year incidence of non-heart death;1-year target cardiomyopathy incidence;1-year incidence of non-targeted cardiomyopathy;Acute stent thrombosis within 24 hours, subacute stent thrombosis within 30 days, and incidence of late stent thrombosis in year 1;1 Year Ischemia-Induced Target Lesions Recurrent;1-year ischemic target lesion re-perfusion;a one-year stroke;Major bleeding rates per year (Bleeding Academic Research Consortium 3-5);For those who have performed 46mm Cre8 stent, whether or not overexpansion through OCT is achieved through OCT;In patients with acute myocardial infarction, the primary/secondary effectiveness of antiplatelet drugs is re-evaluated (clopidogrel vs prasugrel vs ticagrel on acute myocardial infraction)