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 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT04937803
Eligibility Criteria:
Inclusion Criteria:
1. Age≥18 Years and \<80 years;
2. ACS patients eligible for percutaneous coronary intervention;
3. Successful preparation is defined as ≤ 30% residual stenosis with Thrombolysis in Myocardial Infarction (TIMI) Grade III flow and not evidence of type C-F dissection;
4. Vessel diameter from 2.25mm-4.0 mm ;
5. Lesion length ≤ 28 mm;
6. A single culprit lesion or 1 lesion in each of two vessels ;
7. Eligible for enrollment and provide written informed consent.
Exclusion Criteria:
Clinical Exclusion Criteria：
1. Stable angina or asymptomatic myocardial ischemia;
2. Cardiogenic shock or requiring mechanical support for breathing and circulation;
3. Hemodynamically unstable tachyarrhythmia or bradyarrhythmia;
4. Plan to perform cardiac surgery or non-cardiac surgery within 24 months of percutaneous coronary intervention;
5. A history of stroke within 6 months;
6. History of severe renal insufficiency;
7. Life expectancy \< 12 months;
8. Pregnant women;
9. Allergies to aspirin, clopidogrel, ticagrelor, heparin, contrast agents, and paclitaxel, patients with systemic lupus erythematosus or other systemic immune diseases;
10. Patients not suitable for enrollment considered by researcher;
11. Currently participating in another trial before reaching the primary endpoint;
12. Inability to provide informed consent. Image Exclusion Criteria
1\. Chronic total occlusion (CTO); 2. Left main lesion; 3. Bifurcation lesions treated with double stents; 4. Moderate to severe distortion, angulation or severe calcification lesions; 5. Coronary artery graft stenosis; 6. In-stent restenosis; 7. To be re-hospitalized for the other scheduled PCI treatment; 8. Myocardial bridge at the target lesion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04937803
Study Brief:
Protocol Section:
NCT04937803