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:
NCT05101005
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 years and ≤80 years, regardless of gender;
2. De novo lesion in a native coronary artery;
3. Stable angina, or unstable angina, or old myocardial infarction or asymptomatic myocardial ischemia;
4. Reference vessel diameter is 2.75mm-4.0mm with diameter stenosis ≥70% or ≥50% (with evidence of ischemia) and TIMI flow ≥1;
5. The subject can receive any type of coronary vascular revascularization (including balloon angioplasty, stent implantation or coronary artery bypass grafting);
6. The subject who can understand the purpose of the trial, voluntarily participate in and sign an informed consent form, and is willing to accept clinical follow-up.
Exclusion Criteria:
1. Reference vessel diameter \<2.75 mm or \>4.0 mm;
2. In stent restenosis;
3. Left main lesion, chronic complete occlusion lesion;
4. Ostial lesion ≤2mm from the LM, or bifurcation lesion with branch vessel diameter≥2.5mm;
5. There is a large scale of thrombus in the target vessel, and the thrombus grade \>3 after thrombolysis or aspiration;
6. Severe heart failure (NYHA IV);
7. Severe renal failure (GFR\<30ml/min) or undergoing hemodialysis treatment;
8. Severe liver failure (bilirubin is over 2 times the upper limit of normal, or alanine aminotransferase is over 3 times the upper limit of normal);
9. Patients with vein graft restenosis after bypass or severe heart valve disease;
10. Pregnant or breastfeeding female patients;
11. The life expectancy of the patient is less than 12 months;
12. The subject cannot be treated with anticoagulation because of bleeding tendency, history of active peptic ulcer, stroke in the 6 months before surgery, anti-platelet agents or anticoagulant treatment contraindications;
13. Anemia (women's hemoglobin \<117g/L, or men's hemoglobin \<134g/L), or thrombocytopenia detected before the intervention within 6 months (\<100×10⁹/L);
14. Planned to perform non-cardiac surgery within 12 months after index procedure;
15. The subject who participated in other clinical trials of drugs or instruments and did not reach time of primary endpoint;
16. Heart transplant patients;
17. Allergic to aspirin, clopidogrel, heparin, contrast agents, or paclitaxel;
18. The investigator judged that the patient had poor compliance and could not complete the study as required.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05101005
Study Brief:
Protocol Section:
NCT05101005