The PICCOLETO IX PHENO Study (PIX-PHENO)

Fondazione Ricerca e Innovazione Cardiovascolare ETS

Status: Not yet enrolling

Conditions: Coronary Artery Disease

Study type: Observational

Funder types: Other

Identifiers

NCT07390994

PICCOLETO IX - PHENO

Details and patient eligibility

About

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.

Full description

PICCOLETO IX PHENO is an investigator-initiated, multicenter, international, ambispective (retrospective and prospective) cohort study enrolling patients who underwent DCB angioplasty for de novo coronary artery disease with preprocedural OCT assessment of the target segment. OCT images (baseline mandatory; post-preparation and post-PCI when available) and angiography will be analyzed by independent core laboratories; clinical events will be adjudicated by an independent committee. The primary endpoint is clinically-driven target lesion revascularization at 12 months; secondary endpoints include device-oriented composite endpoint (cardiac death, TLR, target-vessel MI), target vessel revascularization, MI endpoints, and mortality.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.