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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT02319733
Eligibility Criteria:
Inclusion Criteria:
* Symptomatic patients between the age of 18 and 80 years
* Morise Risk score of ≥9 (intermediate or high risk) but no proven ischemia (no positive troponin or ST-elevation)
* Intermediate coronary lesion on CT scan (50-70% based on CT estimate) and a plaque with at least two of the following vulnerability criteria: Napkin ring sign, positive remodeling, low attenuation and spotty calcification
* FFR negative lesion at coronary angiogram
* Vessel diameter ≥2.5 mm on visual estimate
* GFR ≥ 45mL/min/1.73m².
Exclusion Criteria:
* High calcium score on CT scan preventing adequate evaluation of the coronary lesion.
* Lesions located in a coronary vessels previously stented.
* Lesions located at a bifurcation
* lesions involving an epicardial side branch ≥2 mm in diameter by visual assessment
* the presence of thrombus or another clinically significant stenosis in the target vessel.
* Left main (\>50%) or known three vessel disease.
* Patients presenting with acute myocardial infarction, unstable arrhythmias, or patients who have a left ventricular ejection fraction \<30%
* Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparine or Everolimus and known true anaphylaxis to prior contrast media or known bleeding diathesis or known coagulopathy.
* Planned elective surgical procedure necessitating interruption of dual antiplatelet therapy during the first 6 months after inclusion.
* History of stent thrombosis
* Malignancies or other comorbidity with a life expectancy of less than one year or that may result in protocol noncompliance
* Pregnancy (present, suspected or planned) or positive pregnancy test (in women with childbearing potential a negative pregnancy test is mandatory)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02319733
Study Brief:
Protocol Section:
NCT02319733