Ischemic Heart Disease
Conditions
Keywords
BioMime, Ultimaster, Ischemic heart disease, DES
Brief summary
Comparison of safety and long-term effects of BioMimeTM stent and Ultimaster® stent with Xience® stent
Detailed description
A prospective, open, multicenter, and observational study will register and compare Xience® groups treated in institutions such as the BioMime ™, Ultimaster® group prospectively registered from June 2016. The Xience® group has already been registered in the previous study (SMARTDESK-BX), so BioMimeTM and Ultimaster® only need to be registered. Follow-up will be conducted until December 2019, and e-CRF will be completed by April 2020.
Interventions
DEVICEBioMimeTM Stent, Ultimaster® Stent
Sponsors
Meril Life Sciences Pvt. Ltd.
Terumo Corporation
Hyeon-Cheol Gwon
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 19 years old or older 2. Clinical evidence of coronary artery disease including asymptomatic ischemia, stable angina pectoris, acute coronary syndrome (unstable angina, non-ST segment elevation myocardial infarction, ST segment elevation myocardial infarction). 3. Vessel diameter 2.25 \ 3.5mm, stenosis more than 50% (However, the number of blood vessels, the number of lesions, and the lesion length are not limited) 4. Voluntary written consent to participate in the trial
Exclusion criteria
1. Within 24 hours before percutaneous coronary intervention, hemodynamic instability or cardiogenic shock 2. Life expectancy within 2 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of 1-year target lesion failure | 1-year | The incidence of 1-year target lesion failure (combination of cardiac death, target vessel myocardial infarction, and target vessel revascularization). |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of 30-day, 1-year, and 2-year deaths | 30-day, 1-year, and 2-year |
| Incidence of 30-day, 1-year, and 2-year cardiac events | 30-day, 1-year, and 2-year |
| Incidence of 30-day, 1-year, and 2-year myocardial infarction | 30-day, 1-year, and 2-year |
| Incidence of 30-day, 1-year, and 2-year target vessel myocardial infarction | 30-day, 1-year, and 2-year |
| Incidence of 30-day and 2-year target lesion failure | 30-day and 2-year |
| Incidence of 30-day, 1-year, and 2-year target revascularization | 30-day, 1-year, and 2-year |
| Incidence of 30-day, 1-year, and 2-year stroke | 30-day, 1-year, and 2-year |
| Incidence of acute stent thrombosis at 24 hours, subacute stent thrombosis at 30 days, and stent thrombosis at 1 and 2 years | 24 hours, 30 days, 1 and 2 years |
| Incidence of 30-day, 1-year, and 2-year revascularization | 30-day, 1-year, and 2-year |
Countries
South Korea
Contacts
Primary ContactHyeon Cheol Gwon
Backup ContactTaek Kyu Park
Outcome results
None listed