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 @ 12:08 PM
Ignite Modification Date:
2025-12-24 @ 12:08 PM
NCT ID:
NCT05222061
Eligibility Criteria:
Inclusion Criteria:
* Main branch and side branch diameter both \>2.5 mm, evaluated based on coronary angiography, performed no later than 6 month before baseline visit;
* Patient ≥18 years old;
* Signed informed consent;
* True bifurcation lesion type 1:1:1 or 0:1:1 or 1:0:1 and
* ischemic symptoms, or
* positive non-invasive imaging for ischemia, or
* positive fractional flow reserve
Exclusion Criteria:
1. ST Elevation Miocardial Infarction \<72 hours preceding;
2. Cardiogenic shock;
3. Chronic total occlusion of either main or side branch of the bifurcation;
4. \>2 other coronary lesions planned for treatment;
5. SYNTAX score \>32;
6. Left main stenosis;
7. In-stent restenosis;
8. Renal function insufficiency: Serum creatinine \> 177 mmol/l; or undergoing hemodialysis;
9. Left ventricular ejection fraction ≤ 30%;
10. Patient life expectancy less than 12 months;
11. Patient's inability to fully cooperate with the study protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05222061
Study Brief:
Protocol Section:
NCT05222061