The PICCOLETO IX PHENO Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prognostic Impact of PHENOtyping de Novo Coronary Artery Disease Prior to Drug-Coated Balloon Angioplasty by Optical Coherence Tomography (PICCOLETO IX PHENO)
Overview
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.
Detailed 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.
Primary outcome measures
- Clinically-driven Target Lesion Revascularization (TLR) [Time frame: 12 months]
Secondary outcome measures (6)
- Device-Oriented Composite Endpoint (DOCE) [Time frame: 12 months]
- Target Vessel Revascularization (TVR) [Time frame: 12 months]
- All-cause Mortality [Time frame: 12 months]
- Cardiac Death [Time frame: 12 months]
- Target-Vessel Myocardial Infarction (TV-MI) [Time frame: 12 months]
- Any Myocardial Infarction [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07390994 · PICCOLETO IX - PHENO