Actively Recruiting
Evaluation of Effectiveness and Safety of Ultimaster Tansei Stent in Routine Clinical Practice A Multicenter, Prospective Observational Study
Led by Duk-Woo Park, MD · Updated on 2024-12-24
2000
Participants Needed
11
Research Sites
536 weeks
Total Duration
On this page
Sponsors
D
Duk-Woo Park, MD
Lead Sponsor
C
CardioVascular Research Foundation, Korea
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness and safety of the Ultimaster17 Tansei17 stent in patients with coronary artery disease during routine clinical practice. The study focuses on real-world daily use of this stent to better understand its outcomes in typical healthcare settings. Participants in this study will receive the Ultimaster17 Tansei17 stent as part of their treatment. The study is observational and takes place across multiple centers, with patients being monitored after receiving the stent. There are no comparison groups; the focus is on those treated with this specific stent. During the study, researchers will follow patients closely, assessing major outcomes such as death, nonfatal heart attacks, or the need for repeat procedures on the treated blood vessel within one year. Participants will have clinical follow-ups according to the study schedule, and safety and effectiveness data will be collected throughout this period to provide a comprehensive view of the stent's performance in everyday medical care.
CONDITIONS
Official Title
Evaluation of Effectiveness and Safety of Ultimaster™ Tansei™ Stent in Routine Clinical Practice
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 19 years old or older
- Patients receiving Ultimaster17 Tansei17 stents
- Patients or guardians who agree to the study protocol, follow-up schedule, and provide written informed consent approved by the Institutional Review Board/Ethics Committee
You will not qualify if you...
- Patients with a mixture of other drug-eluting stents
- Terminal illness with life expectancy of 1 year or less
- Patients with cardiogenic shock
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Gangwon National Univ. Hospital
Chuncheon, South Korea
Actively Recruiting
2
Daegu Catholic University Medical Center
Daegu, South Korea
Actively Recruiting
3
Keimyung University Dongsan Medical Center
Daegu, South Korea
Actively Recruiting
4
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon, South Korea
Actively Recruiting
5
Gangneung Asan Hospital
Gangneung, South Korea
Actively Recruiting
6
Kwangju Christian Hospital
Kwangju, South Korea
Actively Recruiting
7
Pusan National University Hospital
Pusan, South Korea
Actively Recruiting
8
Asan Medical Center
Seoul, South Korea
Actively Recruiting
9
Kangdong Sacred Heart Hospital
Seoul, South Korea
Actively Recruiting
10
The Catholic Univ. of Korea Eunpyeong St. Mary's hospital
Seoul, South Korea
Withdrawn
11
St.Carollo Hospital
Suncheon, South Korea
Actively Recruiting
Research Team
J
Jung-hee Ham, RN
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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