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 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT03040934
Eligibility Criteria:
Clinical Inclusion Criteria:
* CI1. Subject must be at least 18 years of age;
* CI2. Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed;
* CI3. Subject is eligible for percutaneous coronary intervention (PCI);
* CI4. Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia;
* CI5. Subjects are eligible candidates for coronary artery bypass graft surgery (CABG);
* CI6. Left ventricular ejection fraction (LVEF) within 60 days ≥ 35%; Exclusion Criteria;
* CI7. Subject is willing to comply with all protocol-required follow-up evaluation.
Angiographic Inclusion Criteria (visual estimate):
* AI1. Target lesions must be new and have a visually estimated reference diameter ≥2.25 mm and ≤4.0 mm in autologous coronary artery;
* AI2. Target lesions must be \< 100 mm in length (visual estimate) and the number of implanted stents is less than 4;
* AI3. Target lesions must be visually complete occlusion and longer than 4 weeks;
* AI4. Target lesions must be able to pass and be successfully expanded;
Clinical Exclusion Criteria:
* CE1. Subjects recently suffer from MI (within 1 week), and ECG changes/clinical symptoms consistent with AMI or accompanied with increased cardiac biomarkers (CK-MB, CK, TNT or TNI) are excluded;
* CE2. Subjects had an organ transplant or are waiting for an organ transplant;
* CE3. Subjects are receiving chemotherapy or will receive a chemotherapy within 30 days after PCI;
* CE4. Subjects are undergoing chronic (over 72 hours) anticoagulant therapy (such as heparin and coumarin) other than acute coronary syndrome;
* CE5. Subjects with abnormal counts of platelet and white blood cell (WBC): platelet counts less than 100×10E9/L or greater than 700×10E9/L, white blood cells less than 3×10E9/L;
* CE6. Subjects have confirmed or suspected liver disease, including hepatitis lab results;
* CE7. Subjects with elevated serum creatinine level \>3.0mg/dL or undergoing dialysis therapy;
* CE8. Subjects with active peptic ulcer, active gastrointestinal (GI) bleeding or other bleeding diathesis or coagulopathy, or refused a blood transfusion;
* CE9. Subjects with cerebral vascular accident (CVA) or transient ischemic attack (TIA) in the past 6 months, or with permanent nerve defects;
* CE10. Subjects had any PCI (such as balloon angioplasty, stent, cutting balloon,atherectomy) treatment in target vessels (including collateral) within 12 months prior to baseline;
* CE11. Subjects plan to undergo PCI or CABG after the baseline PCI;
* CE12. Subjects have any coronary endovascular brachytherapy treatment previously;
* CE13. Subjects associated with drugs allergy (such as sirolimus, or structure-related compounds fluorinated polymers, thiophenepyridine or aspirin);
* CE14. Subjects are suffering from other serious illness (such as cancer, congestive heart failure), which may cause drop in life expectancy to less than 18 months;
* CE15. Subjects are currently abusing drugs (such as alcohol, cocaine, heroin, etc);
* CE16. Subject plan to undergo any operations that may lead to confuse with the programme;
* CE17. Subjects were participating in another study of drug or medical device which did not meet its primary endpoint;
* CE18. Subjects plan to pregnant within 18 months after baseline;
* CE19. Subjects are pregnant or breastfeeding women.
Angiographic Exclusion Criteria (visual estimate):
* AE1. Target lesions with the following criteria: left main, saphenous vein grafts or arterial grafts, via saphenous vein grafts or arterial graft, and in-stent stenosis;
* AE2. Subjects with unprotected left main coronary artery disease (diameter stenosis \>50%);
* AE3. Subjects have a protected left main coronary artery disease (diameter stenosis\> 50% and left coronary artery bypass surgery), as well as target lesions located in the LAD and LCX;
* AE4. Subjects with other lesions of clinical significance, may be need intervention within 18 months after baseline.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03040934
Study Brief:
Protocol Section:
NCT03040934