Evaluating the Ultimaster Tansei Stent for Coronary Artery Disease
Official title: Evaluation of Effectiveness and Safety of Ultimaster™ Tansei™ Stent and/or Ultimaster Nagomi™ Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Run by Asan Medical Center · NCT04443530 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | Asan Medical Center Academic / other |
| Locations | 11 sites (Chuncheon and 10 other locations) |
| Status | Recruiting |
| Started | September 17, 2020 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2032 |
| Registry record updated | June 26, 2026 |
| Trial ID | NCT04443530 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients aged 19 and older who are receiving Ultimaster Tansei stents.
✕Probably not a fit
Patients with terminal illnesses or those experiencing cardiogenic shock may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
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
Show 5 more locations
-
Asan Medical Center
Seoul, South Korea Recruiting -
Kangdong Sacred Heart Hospital
Seoul, South Korea Recruiting -
St.Carollo Hospital
Suncheon, South Korea Recruiting -
Gangwon National Univ. Hospital
Chuncheon, South Korea Withdrawn -
The Catholic Univ. of Korea Eunpyeong St. Mary's hospital
Seoul, South Korea Withdrawn
Study contacts
- Study coordinator: Jung-hee Ham, RN
- Email: cvcrc5@amc.seoul.kr
- Phone: 82230104728
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
μFR-guided Drug-Coated Balloon Angioplasty vs Angiography-guided Angioplasty in Coronary Artery Disease
This trial tests whether using computational μFR guidance during drug-coated balloon angioplasty is better than standard angiography guidance for people with de novo coronary artery lesions.
-
Gastric Ultrasound Before CABG to See if Heart Function Changes Stomach Contents
This study checks whether people with weaker heart function before elective CABG have different stomach contents seen on ultrasound.
-
Can preoperative photon-counting CT help predict heart recovery after bypass surgery?
This observational study tests whether a preoperative photon-counting CT can help predict heart function 3 months after coronary bypass surgery in adults with coronary artery disease.
-
Real-World Drug-Coated Balloon Angioplasty in Coronary Artery Disease
This registry tests how drug-coated balloons perform in everyday clinical practice for adults with coronary artery disease undergoing PCI.
-
Predicting vasopressor needs after anesthesia in elective on-pump CABG using dynamic arterial elastance
This study tests whether EaDyn measured after induction can help predict which patients will need vasopressors during elective on-pump CABG.
-
Intraoperative Pulse Pressure Variation and Postoperative Lactate Clearance in CABG Patients
This study tests whether the amount a patient’s pulse pressure varies during surgery relates to how quickly lactate levels drop after CABG.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.