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 @ 5:50 PM
Ignite Modification Date:
2025-12-24 @ 5:50 PM
NCT ID:
NCT04641468
Eligibility Criteria:
Inclusion Criteria:
1. Male or non pregnant women aged 18-75 years old;
2. There is clear evidence of myocardial ischemia, including typical ECG changes, non ST segment elevation acute coronary syndrome, ST segment elevation acute myocardial infarction, etc;
3. For mediana 010 or 001 confirmed by coronary angiography, the stenosis was more than 70% by visual inspection and less than 30% at the end of left main artery;
4. They can receive DCB treatment;
5. The reference vessel diameter was 2.00 \~ 4.00 mm;
6. To understand the potential risk of operation and have the intention of DCB treatment.
Exclusion Criteria:
1. Hemodynamic instability, unable to tolerate surgery;
2. The left ventricular ejection fraction was less than 35%;
3. Contrast medium allergy or contraindication for secondary prevention of coronary heart disease;
4. Stents were implanted in the left main trunk;
5. Severe renal insufficiency (EGFR ≤ 30 ml / min / 1.73 m2);
6. Severe infection;
7. Life expectancy is less than one year. All patients signed the informed consent of interventional therapy before operation, and this study was approved by hospital ethics committee.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04641468
Study Brief:
Protocol Section:
NCT04641468