The PICCOLETO IX PHENO Study
ConditionCoronary Artery Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Ricerca e Innovazione Cardiovascolare ETS
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Locations
Sponsors and collaborators
Source ClinicalTrials.gov