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 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT06166459
Eligibility Criteria:
Inclusion Criteria:
1. Subjects at the age between ≥18 and ≤80 years old;
2. De novo native lesion, Median type 010/001 bifurcation lesion;
3. The reference diameter of the target vessel was 2.75-4.0mm and the length was less than 40mm;
4. Subjects are willing to participate in the study, sign informed consent form, and accept clinical follow-up.
Exclusion Criteria:
1. The diameter stenosis of adjacent branch vessel ostium ≥50%;
2. Acute ST-segment elevation myocardial infarction;
3. Stents implanted within 10 mm proximal or distal to the target lesion;
4. Aneurysm within 10 mm proximal or distal to the target lesion;
5. There is target vessel distortion or severe calcification lesion, so balloon catheter fails to pass;
6. Previous coronary artery bypass grafting;
7. Evidence for extensive thrombus within target vessel;
8. Evidence of heart failure by at least one of the following: a. Most recent LVEF ≤35%, or b. Current heart failure defined as dyspnea at rest (NYHA class IV assessed day of procedure), or c. Killip class ≥2 (post STEMI patients);
9. Subjects with a life expectancy of ≤1 year;
10. Subjects with stroke, peptic ulcer, or gastrointestinal bleeding within the past 6 months;
11. Subjects with severe renal failure (eGFR\<30ml/minute), failure to comply with angiography conditions;
12. Subjects who are intolerance to aspirin and/or clopidogrel or ticagrelor or have contraindications;
13. Subjects who are intolerance or allergic to heparin, contrast agent;
14. Patients who are participating in the clinical trial of other drug or device without reaching the time limit of primary endpoint;
15. Subjects who are not applicable to be enrolled by investigators due to other reasons.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06166459
Study Brief:
Protocol Section:
NCT06166459