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 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 1:04 AM
NCT ID:
NCT03383393
Eligibility Criteria:
Inclusion Criteria:
* Subject at least 18 years of age.
* Target lesion(s) located in a native coronary artery with diameter of ≥ 2.5 mm and ≤ 4.5 mm. If there is side branch lesion(s) located in a native coronary artery with diameter of ≥ 2.0 mm.
* Target lesion(s) amenable for PCI with balloon angioplasty of the side branch.
Exclusion Criteria:
* Subjects with significant ST-T change (≥ 1mm).
* Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
* Subjects who refuse to give informed consent.
* Subjects with the following angiographic characteristics: left main coronary artery stenosis, total occlusion target lesion, lesion of interest located at infarct-related artery.
* Subjects with LVEF \< 30%.
* Subjects with moderate or severe degree valvular heart disease or primary cardiomyopathy.
* LBBB, RBBB, atrial fibrillation/flutter with no identifiable isoelectric line.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT03383393
Study Brief:
Protocol Section:
NCT03383393