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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT03056118
Eligibility Criteria:
Inclusion Criteria:
1. Subject must be at least 20 years of age.
2. Subject must have evidence of myocardial ischemia (e.g. stable angina, non-ST elevation acute coronary syndrome, silent ischemia, positive functional study or a reversible changes in the electrocardiogram (ECG) consistent with ischemia).
3. Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving the Resolute Integrity or BioMatrix stent and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
Exclusion Criteria:
1. Acute ST elevation myocardial infarction
2. The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, zotarolimus, biolimus, contrast media
3. Clinical conditions requiring systemic immune suppression over 2 weeks or anti-cancer therapy
4. Prior history of the following presentations: Thromboembolic disease, Stent thrombosis
5. Pregnant women or women with childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
6. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
7. Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
8. Current known current platelet count \< 100,000 cells/mm3 or Hgb \<10 g/dL.
9. Non-cardiac co-morbid conditions are present with life expectancy \< 1 year or that may result in protocol non-compliance (per site investigator's medical judgment
10. Patients with left ventricular ejection fraction \< 35%
11. Patients with cardiogenic shock
12. Creatinine level \> 2.4mg/dL
13. Severe hepatic dysfunction (aspartate aminotransferase and/or alanine aminotransferase ≥ 3 times upper normal reference values)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT03056118
Study Brief:
Protocol Section:
NCT03056118