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 @ 4:34 PM
Ignite Modification Date:
2025-12-24 @ 4:34 PM
NCT ID:
NCT02539966
Eligibility Criteria:
Inclusion Criteria:
* Patient has evidence of myocardial ischemia or a positive functional study
* Target lesion has a visually estimated stenosis of ≥50% and \<100%
* Target lesion is located in a native coronary artery with average reference vessel diameter ≥ 2.5mm and ≤ 3.5mm
* Lesion length ≤ 20 mm by visual estimate (N/A for Cohort C)
* Baseline TIMI flow ≥ 2
Exclusion Criteria:
* The patient has experienced an acute myocardial infarction (AMI: STEMI or NSTEMI) within 72 hours of the procedure and either CK-MB or Troponin has not returned to within 2X ULN.
* Patient has a left ventricular ejection fraction \< 40%
* Patient has unprotected left main coronary disease with ≥50% stenosis
* The target vessel is totally occluded (TIMI Flow 0 or 1)
* Target lesion involves a bifurcation (a lesion with a side branch ≥ 1.5 mm in diameter containing a ≥ 50% stenosis).
* Target lesion is located within a bypass graft
* Target lesion has possible or definite thrombus
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02539966
Study Brief:
Protocol Section:
NCT02539966