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 @ 4:16 AM
Ignite Modification Date:
2025-12-25 @ 4:16 AM
NCT ID:
NCT02280720
Eligibility Criteria:
Inclusion Criteria:
1. Age \>18 and \<80 years
2. STEMI or NSTEMI (assumed by investigator to be type 1 myocardial infarction, according to universal definitions of MI; EHJ 2007; 28(20):2525-38); or unstable angina (clinical symptoms of chest pain, ecg suggestive of reversible ischemia)
3. Patient is willing to comply with specified follow-up evaluations
4. 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, approved by the appropriate Medical Ethics committee or Institutional Review Board
5. Single de novo or non-stented restenosis lesion
6. Patients with two-vessel disease may have undergone successful treatment of the non-target vessel with approved devices up to and including the index procedure but must be prior to the index target vessel treatment
7. Target lesion (maximum 20 mm length by visual estimation) to be covered by a single stent of maximum 23mm length
8. Reference vessel diameter must be \>2.5mm and \<4.0mm by visual estimate.
9. The vessel diameter should be measured after pre-dilation procedure and after intracoronary nitroglycerin if vasospasm is suspected
10. Target lesion \>50% and \<100% stenosed by visual estimate
Exclusion Criteria:
1. Pre-existing diagnosis of diabetes irrespective of its type
2. Impaired renal function (serum creatinine \>177micromol/l) or on dialysis
3. Platelet count \< 10 e5 cells/mm3
4. Patient has a history of bleeding diathesis or coagulopathy or patients in whom antiplatelet and and/or anticoagulation therapy is contraindicated
5. Patient has received organ transplant or is on a waiting list for any organ transplant
6. Patient has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/prasugrel, stainless steel alloy, or contrast agent that cannot be adequately pre-medicated
7. Patient presents with cardiogenic shock
8. Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study
9. Currently participating in another intestigational drug or device study
10. Unprotected left main disease
11. Ostial target lesions
12. Chronic total occlusion
13. Calcified target lesions that cannot be adequately pre-dilated
14. Target lesion has excessive tortuosity unsuitable for stent delivery and deployment
15. Target lesion involving bifurcation with a side branch larger than 2.0mm in diameter
16. A \>30% stenosis proximal or distal to the target lesion that cannot be covered with the same stent
17. Diffuse distal disease
18. Prior stent in the target vessel
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02280720
Study Brief:
Protocol Section:
NCT02280720