The PICCOLETO IX PHENO Study

Starting soon

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT07390994

Run by

Fondazione Ricerca e Innovazione Cardiovascolare ETS

People needed

600

Starts

2026-01-09

Expected to finish

2027-04-20

Last updated by the study team

2026-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

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