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Recruiting Observational

Evaluation of Effectiveness and Safety of Ultimaster™ Tansei™ Stent and/or Ultimaster Nagomi™ Stent in Routine Clinical Practice

NCT04443530 · tracked via the Priya Life Science South Korea tracker
Sponsor
Duk-Woo Park, MD
Phase
Observational
Started
2020-09-17
Last updated
2026-06-26

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

Ultimaster™ Tansei™ stent and/or Ultimaster Nagomi™ stent

Ultimaster™ Tansei™ stent and/or Ultimaster Nagomi™ stent: Patients receiving Ultimaster™ Tansei™ stent and/or Ultimaster Nagomi™ stent

Study summary

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

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patients ≥ 19 years old 2. Patients receiving Ultimaster™ Tansei™ stent and/or Ultimaster Nagomi™ 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

Primary outcome measure(s)

  • The composite event rate of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) — 1 year
    the composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) at 12 months post-procedure. A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event that is considered to have occurred if any one of several different events is observed.

Trial sites (11)

FacilityCityRegionStatus
Gangwon National Univ. Hospital Chuncheon South Korea Withdrawn
Daegu Catholic University Medical Center Daegu South Korea Recruiting
Keimyung University Dongsan Medical Center Daegu South Korea Recruiting
The Catholic University of Korea, Daejeon ST. Mary's Hospital Daejeon South Korea Recruiting
Gangneung Asan Hospital Gangneung South Korea Recruiting
Kwangju Christian Hospital Kwangju South Korea Recruiting
Pusan National University Hospital Pusan South Korea Recruiting
Asan Medical Center Seoul South Korea Recruiting
Kangdong Sacred Heart Hospital Seoul South Korea Recruiting
The Catholic Univ. of Korea Eunpyeong St. Mary's hospital Seoul South Korea Withdrawn
St.Carollo Hospital Suncheon South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04443530 on ClinicalTrials.gov ↗ ← All trials in South Korea