About this trial
\[The Purpose of the Clinical Study\] The purpose of this randomized comparison study is to compare the 1-stent strategy with a drug-eluting balloon and the 2-stent strategy in patients with non-LM coronary true-bifurcation lesions.
\[Hypothesis\] In this study, the researchers intend to verify the hypothesis that the 1-stent strategy with a drug-eluting balloon is non-inferior to the 2-stent strategy in terms of target lesion failures (cardiac death, target vessel MI, or target vessel revascularization).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Patients with myocardial infarction involving an elevated ST segment, or patients with an LM coronary true-bifurcation lesion.
Patients who are ruled out by the treatment provider because the 2-stent strategy was deemed unsuitable to the patient due to a clinical condition.
A patient with aspirin or P2Y12 inhibitors (ticagrelor or clopidogrel) contraindications.
A patient who experienced psychogenic shock at the time of admission, or showed severe left ventricle insufficiency (where the left ventricle ejection fraction is less than 30%.)
Trial design
Crossover
Treatments tested in this trial
Procedure: planed 2-stent strategy
Procedure/SurgeryProcedure: planed 2-stent strategy
Procedure: provisional 1-stent plus DEB strategy
Procedure/SurgeryProcedure: provisional 1-stent plus DEB strategy
Treatment groups
Trial outcomes
Primary outcomes
target lesion failure the number of events
composite outcomes the number of events (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization)
Sponsors and contacts
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