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 @ 7:10 PM
Ignite Modification Date:
2025-12-24 @ 7:10 PM
NCT ID:
NCT02868203
Eligibility Criteria:
Inclusion Criteria:
1. age ≥18 and ≤ 75 years
2. Non-ST-segment elevation MI
3. Patient willing to comply with specified follow-up
5.Patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent 6.Single or two de novo or non-stented restenotic lesion in a native coronary artery 7. Target lesion to be covered by a single stent of max 30 mm . Reference vessel diameter ≥2.25 to ≤ 4.0 mm by visual estimate 8. The vessel diameter should be measured after pre-dilation procedure and after intra-coronary nitroglycerin if spasm is suspected 9. Target lesion ≥70% stenosed by visual estimate
Exclusion Criteria:
1. Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of childbearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test
2. Impaired renal function or on dialysis
3. Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3 or a WBC\<3,000 cells/mm3
4. Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated
5. Patient requires low molecular weight heparin (LMWH) treatment postprocedure or has received a dose of LMWH ≤8 hours prior to index procedure
6. Patient has received any organ transplant or is on a waiting list for any organ transplant;
7. Patient has other medical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (\<1 year)
8. Patient has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, prasugrel, stainless steel alloy, sirolimus and/or contrast sensitivity that cannot be adequately pre-medicated
9. Patient has previously received murine therapeutic antibodies and exhibited sensitization through the production of Human Anti-Murine Antibodies
10. Patient presents with cardiogenic shock
11. Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion;
12. Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study
13. Currently participating in another investigational drug or device study or patient in inclusion in another investigational drug or device study during follow-up
14. Calcified target lesion(s) which cannot be successfully predilated
15. Target lesion has excessive tortuosity unsuitable for stent delivery and deployment;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02868203
Study Brief:
Protocol Section:
NCT02868203