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 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT03716102
Eligibility Criteria:
Inclusion Criteria:
* Subject is an eligible candidate for PCI
* Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia
* Subject is an acceptable candidate for CABG
* Subject has ≤ 3 de novo target lesions in ≤ 2 native coronary artery vessels, with ≤ 2 lesions in a single vessel, each meeting the angiographic criteria and none of the exclusion criteria
* Target lesion(s) must be located in a native coronary artery with RVD ≥ 2.25mm and ≤ 4.00mm
Exclusion Criteria:
* Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmia, or ongoing intractable angina
* Subject's target lesion(s) is located in the left main coronary artery
* Subject's target lesion(s) is located within 3mm of the origin of the LAD or LCX coronary artery
* Subject's target lesion(s) is located within a SVG or an arterial graft
* Subject's target lesion(s) will be accessed via SVG or arterial graft
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03716102
Study Brief:
Protocol Section:
NCT03716102