Actively Recruiting
Comparison of PROVISIONal 1-stent Strategy with Drug-Eluting Balloon Versus Planned 2-stent Strategy in Patients with Non-LM Coronary True-Bifurcation Lesions
Led by Saint Vincent's Hospital, Korea · Updated on 2025-02-10
750
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two treatment strategies for patients with non-left main coronary true-bifurcation lesions, a form of coronary artery disease affecting blood vessel branches. This study aims to compare a provisional 1-stent strategy combined with a drug-eluting balloon to a planned 2-stent strategy. The main goal is to determine whether the simpler 1-stent approach is not worse than the conventional 2-stent method in preventing target lesion failures such as cardiac death, heart attacks, or need for further vessel procedures within one year. The study involves two treatment groups: one receiving stent placement in the main vessel plus a drug-eluting balloon in the branch vessel, with the option for additional stenting if needed; the other receiving stents in both the main and branch vessels following standard techniques chosen by the treatment provider. Decisions about treatment order and bailout stenting depend on specific vessel conditions. The trial uses a randomized design to assign patients to one of these strategies. Participants will be monitored for 12 months after randomization to record any target lesion failures. Assessments will include clinical evaluations and follow-up visits to check heart function and vessel status. The study tracks events like cardiac death, myocardial infarction related to the treated vessel, and the need for repeat procedures. Safety and treatment effectiveness data will be collected throughout this period to compare outcomes between the two approaches.
CONDITIONS
Brief Title
Comparison of PROVISIONal 1-stent Strategy with DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 years or older
- Presence of true bifurcation lesions in coronary arteries with branch vessel diameter 2.25-2.75 mm and main vessel diameter at least 2.5 mm
- Lesions classified as Medina (1,1,1), (1,0,1), or (0,1,1) and are de novo
- Clinical diagnosis of stable angina, unstable angina, or non-ST elevation myocardial infarction at least 24 hours after last treatment
- Understanding of study groups and risks, and voluntary informed consent given by patient or legal representative
You will not qualify if you...
- Myocardial infarction with ST segment elevation
- Left main coronary true-bifurcation lesion
- Unsuitability for 2-stent strategy as judged by treatment provider
- Contraindications to aspirin or P2Y12 inhibitors (ticagrelor or clopidogrel)
- Psychogenic shock at admission or severe left ventricle insufficiency (ejection fraction less than 30%)
- Requirement for prolonged anticoagulation (warfarin or new oral anticoagulants)
- Active bleeding or high risk of major bleeding (including active peptic ulcer, high-risk gastrointestinal lesions, or malignant tumors with bleeding risk)
- History of intracerebral hemorrhage or aneurysm
- Planned surgery requiring antiplatelet treatment within 6 months
- Severe liver disease with abdominal effusion
- Platelet count below 80,000 cells/mm3 or hemoglobin below 10 g/dL
- Risk of bradycardia without permanent pacemaker and grade 2 or higher atrioventricular block
- Positive pregnancy test or current breastfeeding
- Life expectancy less than one year due to other illnesses
- Participation in another randomized clinical study with unresolved primary endpoint
- Lack of signed informed consent or inability to be followed long-term
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 - Single procedure with immediate treatment period
Participants receive one of two stenting strategies to treat coronary bifurcation lesions: either a provisional 1-stent plus drug-eluting balloon strategy or a planned 2-stent strategy, as determined by random assignment and treatment provider discretion.
1 procedure visit (in-person)
Duration - 12 months
Participants are monitored for clinical outcomes including target lesion failure for 12 months after treatment.
Regular follow-up visits according to study schedule
Trial Site Locations
Total: 1 location
1
St. Vincent's Hospital , the Catholic University
Suwon, Gyeonggi-do, South Korea, 16247
Actively Recruiting
Research Team
S
Sung-Ho Her, MD. PhD.
K
Kyusup Lee, MD. PhD.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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