Registry in Korea: BioMimeTM Stent, Ultimaster® Stent vs. Xience® Stent (SMARTDESK-MX)

Hyeon-Cheol Gwon

Status: Unknown

Conditions: Ischemic Heart Disease

Treatments: Device: BioMimeTM Stent, Ultimaster® Stent

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02986295

2016-04-059

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,000 participants in 2 patient groups

BioMimeTM Stent

Description:

No intervention / Ischemic heart disease with percutaneous coronary intervention with BioMimeTM Stent

Treatment:

Device: BioMimeTM Stent, Ultimaster® Stent

Ultimaster® Stent

Description:

No intervention / Ischemic heart disease with percutaneous coronary intervention with Ultimaster® stent

Treatment:

Device: BioMimeTM Stent, Ultimaster® Stent