Registry in Korea: BioMimeTM Stent, Ultimaster® Stent vs. Xience® Stent

Hyeon-Cheol Gwon2,000 enrolled

Overview

Comparison of safety and long-term effects of BioMimeTM stent and Ultimaster® stent with Xience® stent

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.

Study Type

OBSERVATIONAL

Enrollment

2,000

Conditions

Ischemic Heart Disease

Interventions

BioMimeTM Stent, Ultimaster® StentDEVICE

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

The incidence of 1-year target lesion failure

The incidence of 1-year target lesion failure (combination of cardiac death, target vessel myocardial infarction, and target vessel revascularization).

Time frame: 1-year