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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07390994
Eligibility Criteria:
Inclusion Criteria:
* Chronic coronary syndrome or acute coronary syndrome diagnosis (per ESC guidelines).
* De novo obstructive CAD: ≥50% left main stenosis, or any stenosis ≥70%, or FFR \<0.80 in any other major epicardial vessel, or MLA deemed ischemic at intravascular imaging.
* OCT assessment of the target segment phenotype prior to lesion preparation and DCB angioplasty.
* Successful DCB angioplasty according to DCB ARC criteria.
* Patients who underwent DCB-only PCI, or hybrid DCB-DES PCI with at least 20 mm of the target segment treated with DCB.
Exclusion Criteria:
* Previous revascularization of the target segment with stent.
* Hybrid DCB-DES PCI with DCB-treated segment \<20 mm and/or lacking complete OCT assessment of the DCB-treated segment and/or bailout stenting.
* Lack of at least 6 months of clinical follow up.
* PCI of chronic total occlusion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07390994
Study Brief:
Protocol Section:
NCT07390994