Clinical trial NCT02986295: Registry in Korea: BioMimeTM Stent, Ultimaster® Stent vs. Xience® Stent
Official title: Real World Drug-Eluting Stent Prospective, Open, Multi-site, Registry in Korea: BioMimeTM Stent, Ultimaster® Stent vs. Xience® Stent By SMart Angioplastry Research Team (SMARTDESK-MX)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Heart Disease
Keywords: BioMime, Ultimaster, Ischemic heart disease, DES
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Meril Life Sciences Pvt. Ltd.
name: Terumo Corporation
First posted: 2016-12-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ischemic heart disease with percutaneous coronary intervention with stenting

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.

Eligibility criteria: 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

Primary outcomes:
measure: The incidence of 1-year target lesion failure
timeFrame: 1-year
Secondary outcomes:
measure: Incidence of 30-day and 2-year target lesion failure
timeFrame: 30-day and 2-year
measure: Incidence of 30-day, 1-year, and 2-year deaths
timeFrame: 30-day, 1-year, and 2-year
measure: Incidence of 30-day, 1-year, and 2-year cardiac events
timeFrame: 30-day, 1-year, and 2-year
measure: Incidence of 30-day, 1-year, and 2-year myocardial infarction
timeFrame: 30-day, 1-year, and 2-year
measure: Incidence of 30-day, 1-year, and 2-year target vessel myocardial infarction
timeFrame: 30-day, 1-year, and 2-year
measure: Incidence of 30-day, 1-year, and 2-year revascularization
timeFrame: 30-day, 1-year, and 2-year
measure: Incidence of 30-day, 1-year, and 2-year target revascularization
timeFrame: 30-day, 1-year, and 2-year
measure: Incidence of 30-day, 1-year, and 2-year stroke
timeFrame: 30-day, 1-year, and 2-year
measure: Incidence of acute stent thrombosis at 24 hours, subacute stent thrombosis at 30 days, and stent thrombosis at 1 and 2 years
timeFrame: 24 hours, 30 days, 1 and 2 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Hyeon Cheol Gwon
role: STUDY_CHAIR
References:
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