Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT06002932
Eligibility Criteria:
Inclusion Criteria:
① 19+ years old
② Patients with the following lesions and clinical factors. 2-1. The lesion factor: Visually confirmed diameter of the 2.25-2.75 mm in branched vessels, where the main blood vessel's diameter is at least 2.5 mm; the lesion at the branched vessels is of a Medina classification (1,1,1), (1,0,1), or (0,1,1), with a true bifurcation; a de novo lesion.
2-2 Clinical factors: Stable angina pectoris, unstable angina pectoris, or myocardial infarction with an elevated non-ST segment, all at least 24 hours after their last treatment.
③ Patients who understood the definitions of the test group and the control group and the risks involved in the treatment, and with voluntary, informed consent to participate in the study, as provided either by the patient or their legal representatives.
Exclusion Criteria:
* 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%.)
* A patient who requires prolonged anti-coagulative treatment (warfarin or a new oral anti-coagulant \[NOAC\])
* A patient who is currently hemorrhagic, or has a high risk of major hemorrhage (active peptic ulcer, GI lesions with high hemorrhagic risks, malicious tumors with a high risk of hemorrhage) ⑦ A patient with a history of intra-cerebral hemorrhage or intra-cerebral aneurysm.
* A patient for whom surgery that requires antiplatelet treatment intervention is scheduled within the next six months.
⑨ A patient with severe hepatic diseases (abdominal effusion) Platelet count at less than 80,000 cells/mm3 Hgb count at less than 10 g/dL
⑩ A patient who appears to be at risk of bradycardia (a patient with an insufficiency of the said function, or a patient without a permanent pacemaker despite a grade 2 or higher atrioventricular block).
⑪ A patient who tested positive in a pregnancy test, or is currently breastfeeding
⑫ A patient with less than one year of remaining life expectancy due to comorbidity (based on the medical judgment of the investigator).
⑬ A patient who is already participating in another randomized clinical study for other medicines or medical devices, where the primary end point has not been reached.
⑭ A patient who did not sign her informed consent form, or could not be traced in the long-term.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT06002932
Study Brief:
Protocol Section:
NCT06002932