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 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
NCT ID:
NCT02688868
Eligibility Criteria:
Inclusion Criteria:
1. 18-80 years of age, males or non-pregnant women;
2. Evidence of silent ischemia, stability or in patients with old myocardial infarction or unstable angina;
3. Primary target lesion, in situ coronary artery disease;
4. Target lesion length ≤ 60mm, target lesion diameter 2.25mm (Visual method);
5. The target lesion diameter stenosis ≥ 70% (Visual method);
6. Each target lesion implantation the same stent (Firehawk stent);
7. With indications for coronary artery bypass surgery;
8. To understand the purpose of testing, voluntary and informed consent, patients agreed to achieve invasive imaging and clinical follow-up.
Exclusion Criteria:
1. Within 72h of any acute myocardial infarction;
2. Unprotected left main coronary artery disease, triple vessel lesions which need treated all; bifurcation lesions and vascular lesions of the bridge;
3. Severe calcified lesions that cannot be successfully expanded and distorting lesions not suitable for stent delivery;
4. Artery and/or vein bypass graft lesions;
5. Intracoronary implantation of any branding stents within 1 year;
6. Severe congestive heart failure (NYHA class III and above), or left ventricular ejection fraction \<35% (ultrasound or left ventricular angiography);
7. Preoperative renal function serum creatinine \>2.0mg/DL;
8. Bleeding, active gastrointestinal ulcers, brain hemorrhage or subarachnoid hemorrhage and half year history of ischemic stroke, antiplatelet agents and would not allow an anticoagulant therapy contraindications patients undergoing antithrombotic therapy;
9. Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer and rapamycin allergies;
10. The patient's life expectancy is less than 12 months;
11. Top participated in other drug or medical device and does not meet the primary study endpoint in clinical trials time frame;
12. Researchers determine patient compliance is poor, unable to complete the study in accordance with the requirements;
13. Heart transplantation patients.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02688868
Study Brief:
Protocol Section:
NCT02688868