Actively Recruiting
Evaluation of Effectiveness and Safety of Rotational Atherectomy in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Led by Seung-Jung Park · Updated on 2026-01-02
500
Participants Needed
8
Research Sites
260 weeks
Total Duration
On this page
Sponsors
S
Seung-Jung Park
Lead Sponsor
C
CardioVascular Research Foundation, Korea
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of rotational atherectomy, a procedure used to treat coronary artery disease, in routine clinical practice. This multicenter, prospective observational study focuses on patients with atherosclerosis and coronary stenosis who receive this intervention, aiming to better understand its outcomes in real-world settings. Participants undergo percutaneous coronary intervention with rotational atherectomy as part of their clinical care. This study does not involve randomization or placebo control but observes the outcomes following the procedure. The study tracks patients over time to assess various outcomes related to the procedure and disease progression. Throughout the study, researchers will monitor participants for target vessel failure at one year, as well as other outcomes including death, cardiac death, myocardial infarction, revascularization procedures, stent thrombosis, stroke, and procedural success over periods extending up to five years. Follow-up visits and data collection are scheduled at multiple intervals to gather comprehensive information on safety and effectiveness. Total participation duration depends on individual follow-up schedules.
CONDITIONS
Brief Title
Evaluation of Effectiveness and Safety of Rotational Atherectomy in Routine Clinical Practice
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 19 years old or older
- Patients who have received rotational atherectomy
- Patient or guardian agrees to study protocol and follow-up schedule and provides informed written consent
You will not qualify if you...
- Life expectancy less than 1 year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day
Participants undergo rotational atherectomy as part of routine clinical care.
1 visit (in-person)
Duration - Up to 5 years
Participants are followed to assess effectiveness and safety outcomes including vessel failure, death, myocardial infarction, and revascularization up to 5 years after the procedure.
Visits at 1, 6, and 12 months, and annually at Years 3 and 5
Trial Site Locations
Total: 8 locations
1
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, South Korea
Actively Recruiting
2
Daegu Catholic University Medical Center
Daegu, South Korea
Actively Recruiting
3
Chungnam National University Hospital
Daejeon, South Korea
Terminated
4
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon, South Korea
Withdrawn
5
Chonnam National University Hospital
Gwangju, South Korea
Not Yet Recruiting
6
Inje University Pusan Paik Hospital
Pusan, South Korea
Terminated
7
Bundang CHA Hospital
Seongnam, South Korea
Terminated
8
Asan Medical Center
Seoul, South Korea
Actively Recruiting
Research Team
S
Seung-jung Park, MD
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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