NCT07390994Not yet recruiting
The PICCOLETO IX PHENO Study
Prognostic Impact of PHENOtyping de Novo Coronary Artery Disease Prior to Drug-Coated Balloon Angioplasty by Optical Coherence Tomography (PICCOLETO IX PHENO)
Source: ClinicalTrials.gov · Last updated 5 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 29 Jan 2026
- Start date
- 9 Jan 2026
- Primary completion date
- 10 Mar 2027
- Lead sponsor
- Fondazione Ricerca e Innovazione Cardiovascolare ETS
- Diseases
- Coronary artery disease
- NCT number
- NCT07390994
What you commit to
- Study type: Observational
- Planned participants: 600
- From 9 Jan 2026 to the primary completion date, 10 Mar 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous revascularization of the target segment with stent.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.