The PICCOLETO IX PHENO Study (NCT07390994) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The PICCOLETO IX PHENO Study
600 participantsStarted 2026-01-09
Plain-language summary
To investigate whether pre-procedural OCT-derived de novo coronary lesion phenotype (lipid-rich, fibrotic, calcific; and ACS mechanisms such as plaque rupture/erosion/calcified nodule) is associated with clinical outcomes after DCB angioplasty.
Who can participate
Age range18 Years
SexALL
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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.