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 @ 7:41 PM
Ignite Modification Date:
2025-12-24 @ 7:41 PM
NCT ID:
NCT01986803
Eligibility Criteria:
Inclusion Criteria:
1. Subject must be at least 18 years of age;
2. Primary PCI within 24 hours of symptom onset;
3. ST-segment elevation of \> 1mm in \> 2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of \>1mm in \>2 contiguous anterior leads;
4. Presence of at least one acute infarct artery target vessel with one or more coronary artery stenoses in a native coronary artery within planned device deployment segment (Dmax) by visual estimation of ≥ 2.5 mm and ≤ 3.8 mm;
5. Subject agrees to not participate in any other investigational or invasive clinical study for a period of 6 months following the index procedure.
Exclusion Criteria:
1. Inability to provide informed consent;
2. Known pregnancy at time of randomization. Female who is breastfeeding at time of randomization;
3. Known intolerance to aspirin, heparin, PLLA (poly(L-lactic acid), everolimus, contrast material;
4. Cardiogenic Shock;
5. Unprotected left main coronary artery stenosis;
6. Distal occlusion of target vessel;
7. Acute myocardial infarction secondary to stent thrombosis;
8. Mechanical complications of acute myocardial infarction;
9. Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in sub-optimal imaging or excessive risk of complication from placement of an OFDI catheter;
10. Fibrinolysis prior to PCI;
11. Active bleeding or coagulopathy or patients at chronic anticoagulation therapy;
12. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01986803
Study Brief:
Protocol Section:
NCT01986803