Evaluation of Effectiveness and Safety of Ultimaster™ Tansei™ Stent in Routine Clinical Practice (IRIS Tansei)

Duk-Woo Park, MD

Status: Enrolling

Conditions: Coronary Artery Disease

Treatments: Drug: Ultimaster™ Tansei™ stents

Study type: Observational

Funder types: Other

Identifiers

NCT04443530

AMCCV2020-07

Details and patient eligibility

About

This study is to evaluate the effectiveness and safety of Ultimaster Tansei stent in the "real-world" daily practice.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients ≥ 19 years old
2. Patients receiving Ultimaster™ Tansei™ stents.
3. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

Exclusion criteria

1. Patients with a mixture of other drug-eluting stents (DESs)
2. Terminal illness with life-expectancy ≤1 year.
3. Patients with cardiogenic shock

Trial design

2,000 participants in 1 patient group

Coronary artery stenosis

Description:

Patients with coronary artery disease

Treatment:

Drug: Ultimaster™ Tansei™ stents