Registry in Korea: BioMimeTM Stent, Ultimaster® Stent vs. Xience® Stent
- Conditions
- Ischemic Heart Disease
- Interventions
- Device: BioMimeTM Stent, Ultimaster® Stent
- Registration Number
- NCT02986295
- Lead Sponsor
- Hyeon-Cheol Gwon
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2000
Inclusion Criteria
- 19 years old or older
- 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).
- 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)
- Voluntary written consent to participate in the trial
Exclusion Criteria
- Within 24 hours before percutaneous coronary intervention, hemodynamic instability or cardiogenic shock
- Life expectancy within 2 years
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description BioMimeTM Stent BioMimeTM Stent, Ultimaster® Stent No intervention / Ischemic heart disease with percutaneous coronary intervention with BioMimeTM Stent Ultimaster® Stent BioMimeTM Stent, Ultimaster® Stent No intervention / Ischemic heart disease with percutaneous coronary intervention with Ultimaster® stent
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Incidence of 30-day and 2-year target lesion failure 30-day and 2-year 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, 1-year, and 2-year revascularization 30-day, 1-year, 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
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of