Actively Recruiting
Evaluation of Effectiveness and Safety of Antegrade and Retrograde Approach of Percutaneous Coronary Intervention for Chronic Total Occlusions; Systemic Chronic Total Occlusion Revascularization Korea Research-Chronic Total Occlusion (STRIKE-CTO) Study
Led by Seung-Whan Lee, M.D., Ph.D. · Updated on 2024-12-27
4000
Participants Needed
32
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Seung-Whan Lee, M.D., Ph.D.
Lead Sponsor
A
Abbott Medical Devices
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the differences, success rates, complications, and long-term outcomes of two approaches used in procedures for chronic total occlusion (CTO) of coronary arteries. The study aims to analyze clinical, anatomical, and procedural factors in patients undergoing the antegrade or retrograde approach for this heart condition. It also seeks to identify which patients require the retrograde approach and the factors affecting long-term results after these procedures. The study observes patients who have undergone percutaneous coronary intervention (PCI) for CTO using either the antegrade or retrograde approach. It compares these approaches in terms of procedure success and complications. The study collects data at multiple time points, including up to five years after the procedure, to assess outcomes such as death, heart attack, and vessel revascularization or reocclusion. Participants will be monitored through clinical follow-up plans approved by institutional review boards. Researchers measure outcomes like death, myocardial infarction, and vessel revascularization at 12 months after PCI and annually for up to five years. The study involves tracking procedural success and complications to understand long-term performance and safety of the two approaches for treating coronary CTO.
CONDITIONS
Brief Title
Evaluation of Effectiveness and Safety of Antegrade and Retrograde Approach of Percutaneous Coronary Intervention for Chronic Total Occlusions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 19 years or older
- Patients with a chronic total occlusion lesion in at least one epicardial coronary artery with a vessel diameter of 2.5 mm or more
- Patients experiencing angina symptoms or with confirmed myocardial ischemia, including asymptomatic myocardial ischemia, stable or unstable angina, or non-ST-segment elevation myocardial infarction
- Patients who voluntarily agree to the study protocol and clinical follow-up plan and have signed informed consent approved by the study institute's IRB
You will not qualify if you...
- Patients who are pregnant, breastfeeding, or have childbearing potential
- Patients allergic or with contraindications to contrast medium, heparin, aspirin, clopidogrel, ticagrelor, prasugrel, or cilostazol
- Patients scheduled for surgery requiring stopping antiplatelet drugs within 12 months after study participation
- Patients with acute ST elevation myocardial infarction at hospitalization
- Terminally ill patients with life expectancy less than one year
- Patients with serious diseases other than cardiac conditions that may limit life expectancy or study observation, such as severe chronic obstructive pulmonary disease, persistent hepatitis or severe liver failure, severe kidney disease, as determined by the investigator
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 - Up to 5 years
Participants who undergo routine care are observed to compare clinical, anatomical, and periprocedural factors between antegrade and retrograde approaches for coronary chronic total occlusions.
Annual visits for up to 5 years
Trial Site Locations
Total: 32 locations
1
Hallym University Sacred Heart Hospital
Anyang, South Korea
Actively Recruiting
2
SoonChunHyang University Hospital Bucheon
Bucheon-si, South Korea
Actively Recruiting
3
Gyeongsang National University Changwon Hospital
Changwon, South Korea
Actively Recruiting
4
Chungbuk National University Hospital
Cheongju-si, South Korea
Actively Recruiting
5
Gangwon National University Hospital
Chuncheon, South Korea
Actively Recruiting
6
Keimyung University Dongsan Medical Center
Daegu, South Korea
Actively Recruiting
7
Yeungnam University Medical Center
Daegu, South Korea
Actively Recruiting
8
Chungnam National University Hospital
Daejeon, South Korea
Actively Recruiting
9
the Catholic University of Korea, Daejeon St. Mary'S Hospital
Daejeon, South Korea
Actively Recruiting
10
The Catholic University of Korea, ST. Vincent's Hospital
Daejeon, South Korea
Actively Recruiting
11
Gangneung Asan Hospital
Gangneung, South Korea
Actively Recruiting
12
Myongji Hospital
Goyang-si, South Korea
Actively Recruiting
13
Hanyang University Medical Center
Guri-si, South Korea
Actively Recruiting
14
Gwangju Veterans Hospital, Korea Veterans Health Service
Gwangju, South Korea
Not Yet Recruiting
15
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, South Korea
Actively Recruiting
16
Seoul national university Bundang hospital
Gyeonggi-do, South Korea
Actively Recruiting
17
Inha University Hospital
Incheon, South Korea
Actively Recruiting
18
The Catholic University of Korea, Incheon ST. MARY'S Hospital
Incheon, South Korea
Actively Recruiting
19
Busan Veterans Hospital, Korea Veterans Health Service
Pusan, South Korea
Actively Recruiting
20
Dong-A University Hospital
Pusan, South Korea
Actively Recruiting
21
Gosin University Gospel Hospital
Pusan, South Korea
Actively Recruiting
22
Inje University Haeundae Paik Hospital
Pusan, South Korea
Actively Recruiting
23
Inje University Pusan Paik Hospital
Pusan, South Korea
Actively Recruiting
24
Chungnam National University Sejong Hospital
Sejong, South Korea
Actively Recruiting
25
Asan Medical Center
Seoul, South Korea
Actively Recruiting
26
Kangbuk Samsung Hospital
Seoul, South Korea
Actively Recruiting
27
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
28
The Catholic University of Korea, Eunpyeong
Seoul, South Korea
Actively Recruiting
29
The Catholic University of Seoul St. Mary's Hospital
Seoul, South Korea
Actively Recruiting
30
Veterans Hospital Service Medical Center
Seoul, South Korea
Actively Recruiting
31
Ulsan University Hospital
Ulsan, South Korea
Actively Recruiting
32
Pusan National University Yangsan Hospital
Yangsan, South Korea
Actively Recruiting
Research Team
S
Seung-Whan Lee, MD
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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