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:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT06521905
Eligibility Criteria:
Inclusion Criteria:
1. Age range: 18-80 years old, male or non pregnant female
2. The patient or guardian can voluntarily sign and understand the informed consent form, and can accept follow-up
3. Asymptomatic ischemic, stable or unstable angina or myocardial infarction (MI) (including ST segment elevation and non ST segment elevation MI) with chest pain onset to hospital admission time\>24 hours, as well as old myocardial infarction patients
4. Visually assess the target lesion with a reference vessel diameter of 2.5-4.0mm, diameter stenosis degree ≥ 70% or ≥ 50%, and evidence of ischemia
5. The target lesion is the only lesion that requires treatment this time
6. Patients suitable for percutaneous coronary stent implantation
7. Confirmed by coronary angiography or IVUS testing that the target lesion is calcified, with any degree of calcification
8. After surgical treatment for calcified lesions, IVUS testing confirmed that it meets the criteria for incomplete stent expansion
Exclusion Criteria:
Exclusion criteria for patient level:
1. Individuals with abnormal coagulation function tests
2. Patients with severe hemodynamic disorders
3. Clinical manifestations of heart failure with LVEF\<30%
4. I have experienced an acute myocardial infarction in the past week
5. Patients allergic to heparin, contrast agents, antiplatelet drugs, anticoagulants, anesthetics, etc
6. Patients with severe myocardial bridge/negative remodeling or target vessel thrombosis
7. Pregnant or lactating women
8. Patients with malignant tumors or comorbidities with a life expectancy of less than 12 months
9. History of active peptic ulcer or gastrointestinal bleeding within 6 months prior to enrollment
10. Stroke occurred within 6 months prior to enrollment, excluding transient ischemic attack (TIA) and cerebral infarction
11. Severe liver and kidney function impairment, transaminase levels exceeding the upper limit of normal by more than three times, creatinine levels greater than 2.5mg/dL (221 μ moI/L), or chronic renal failure requiring long-term dialysis
12. Anti thrombotic therapy intolerance
13. Severe anemia, thrombocytopenia, or leukopenia
14. History of severe bleeding (intracranial, gastrointestinal)
15. Also participating in other patients who have not completed clinical trials at the same time
16. Patients with poor compliance and inability to complete the study on time
17. Other situations deemed unsuitable by researchers to participate in this clinical study
Exclusion criteria for vascular level:
1. Thrombotic lesion
2. Bridge vascular disease
3. Angiography shows tortuous vascular pathways, making it difficult for experimental instruments to reach the target position or retrieve them
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06521905
Study Brief:
Protocol Section:
NCT06521905