Evaluating the Ultimaster Tansei Stent for Coronary Artery Disease
Evaluation of Effectiveness and Safety of Ultimaster™ Tansei™ Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study
This study is testing how well the Ultimaster Tansei stent works and is safe for people with coronary artery disease in real-life situations.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Asan Medical Center Academic / other |
| Locations | 11 sites (Chuncheon and 10 other locations) |
| Trial ID | NCT04443530 on ClinicalTrials.gov |
What this trial studies
This study assesses the effectiveness and safety of the Ultimaster Tansei stent in treating patients with coronary artery disease in everyday clinical settings. It involves monitoring patients who receive this specific stent and collecting data on their outcomes over time. The observational nature of the study allows for real-world insights into the stent's performance and patient experiences.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 19 and older who are receiving Ultimaster Tansei stents.
Not a fit: Patients with terminal illnesses or those experiencing cardiogenic shock may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the safety and effectiveness of the Ultimaster Tansei stent, potentially improving treatment options for patients with coronary artery disease.
How similar studies have performed: While this study focuses on a specific stent, similar observational studies have shown success in evaluating the effectiveness of various stents in real-world settings.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chuncheon and 10 other locations
- Gangwon National Univ. Hospital — Chuncheon, South Korea (Recruiting)
- 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)
Study contacts
- Study coordinator: Jung-hee Ham, RN
- Email: cvcrc5@amc.seoul.kr
- Phone: 82230104728
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.