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 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT02831205
Eligibility Criteria:
Inclusion Criteria:
* Age 18 and more
* Diffuse long native coronary artery stenosis (\>50% by visual estimate) with lesion length of more than 40 mm requiring at least 2 overlapped stents with a reference-vessel diameter of 2.5 to 3.75 mm on visual assessment
* Patients with silent ischemia, stable or unstable angina pectoris, and acute myocardial infarction including NSTEMI or STEMI
* The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site
Exclusion Criteria:
* Subject has known hypersensitivity or contraindication to device material and its ingredients (everolimus, poly(L-lactide), poly(DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic, and fluoro polymers that cannot be adequately premedicated
* Subject has known allergic reaction, hypersensitivity, or contraindication to aspirin; to clopidogrel and prasugrel and ticagrelor; or to heparin and therefore cannot be adequately treated with study medication
* An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs within 12 m after the procedure
* STEMI requiring primary percutaneous coronary intervention
* Cardiogenic shock
* Restenotic lesions
* Left main
* Extreme angulation (≥90°) or excessive tortuosity (≥two 45° angles) proximal to or within the target lesion
* Heavy calcification proximal to or within the target lesion
* Compromised left ventricular dysfunction (LVEF \<30%)
* At the time of screening, the subject has a malignancy that is not in remission
* Terminal illness with life expectancy \<1 year
* Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
* Patient's pregnant or breast-feeding or child-bearing potential
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02831205
Study Brief:
Protocol Section:
NCT02831205