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 @ 7:22 PM
Ignite Modification Date:
2025-12-24 @ 7:22 PM
NCT ID:
NCT04072003
Eligibility Criteria:
Inclusion Criteria:
1. Patients with stable or unstable angina pectoris, asymptomatic myocardial ischemia or attack of myocardial infarction \>24 h;
2. True bifurcation lesion of left main coronary artery (Medina 1,1,1 or 0,1,1);
3. According to coronary angiography, the opening stenosis of the left anterior descending (LAD) and left circumflex (LCX) is more than 50% visually;
4. The operator judges that the lesion is suitable for drug eluting stent(DES) implantation;
5. Branch vessel diameter ≥2.5 mm by visual inspection;
Exclusion Criteria:
1. Pregnant or lactating women;
2. Combined with other diseases, life expectancy \<1 year;
3. A surgery is scheduled within 6 months after the operation, and this surgery affects continuous administration of antiplatelet drugs;
4. The dual antiplatelet therapy cannot be tolerated;
5. Follow - up visits required by the protocol cannot be followed, or the investigators believe that the participation of subjects in the trial will increase the risk;
6. Unable to provide written informed consent form, or unable to follow the trial protocol;
7. Participate in another clinical trial of coronary interventional device;
8. Subjects with myocardial infarction within 24 h of onset of chest pain (including ST segment elevation or non - ST segment elevation);
9. Suffer from renal failure requiring dialysis treatment or is undergoing dialysis treatment;
10. Hemoglobin \<9 g/L;
11. Uncontrolled hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥ 110 mmHg);
12. Severe cardiac insufficiency (LVEF \<30%);
13. Heart failure complicated with pulmonary hypertension (mean pulmonary artery pressure(mPAP) ≥25 mmHg,pulmonary capillary wedge pressure (PCWP) \>15 mmHg, and pulmonary vascular resistance (PVR)\>3.0WU);
14. Complicated with hypertrophic obstructive cardiomyopathy;
15. Re-stenotic bifurcation lesion;
16. Severe calcified lesions requiring rotational atherectomy;
17. Chronic total occlusion lesion without successful recanalization;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04072003
Study Brief:
Protocol Section:
NCT04072003