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 @ 1:21 PM
Ignite Modification Date:
2025-12-24 @ 1:21 PM
NCT ID:
NCT06154395
Eligibility Criteria:
Inclusion Criteria:
Clinical Inclusion Criteria:
1. Subjects aged ≥18 years;
2. Initial diagnosis of anterior wall ST-segment elevation myocardial infarction, with symptoms occurring within 6 hours, and undergoing primarypercutaneous coronary intervention (PCI);
3. Subjects (or legal representatives) who understand the study requirements and treatment procedures and provide signed informed consent.
Imaging Inclusion Criteria (Visual Estimation):
1. Target lesion is the culprit lesion, located in the native coronary artery, with a visually estimated reference vessel diameter (RVD) between 2.25 mm and 4.0 mm;
2. Culprit segment of the infarct-related artery (IRA) is located between the origin of the left anterior descending (LAD) artery and the emergence of the second diagonal branch (D2);
3. After pre-treatment , the degree of stenosis in the LAD is ≤90%, and TIMI flow is grade 3.
Exclusion Criteria:
Clinical Exclusion Criteria:
1. History of coronary artery bypass grafting (CABG);
2. Known history of myocardial infarction or PCI;
3. Previous thrombolytic therapy before PCI;
4. Severe liver or kidney dysfunction, severe valvular heart disease, chronic obstructive pulmonary disease, etc.;
5. Contraindications to magnetic resonance imaging;
6. Allergy to gadolinium contrast agents and/or accompanying medications for devices or procedures (e.g., any component of drug-eluting stents, all P2Y12 inhibitors, or aspirin);
7. Expected lifespan of the subject less than 12 months;
8. Pregnant or lactating females;
9. Other subjects deemed unsuitable for participation in the study by the investigator.
Imaging Exclusion Criteria (Visual Estimation):
1. Presence of lesions requiring intervention other than the target lesion at baseline surgery;
2. No protected left main coronary artery disease (visual estimate of stenosis \>50%);
3. Diffuse severe calcification (\>20 mm) or chronic total occlusion in the major coronary vessels (LCX, RCA);
4. Severe coronary artery tortuosity (\>45°) or calcification (\>270°), or other conditions that may interfere with the use of intravascular imaging.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06154395
Study Brief:
Protocol Section:
NCT06154395