Coronary Artery Disease
Conditions
Keywords
Drug-Coated Balloon, Optical Coherence Tomography, Percutaneous Coronary Intervention, Plaque phenotype
Brief summary
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.
Interventions
None listed
Sponsors
Fondazione Ricerca e Innovazione Cardiovascolare ETS
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinically-driven Target Lesion Revascularization (TLR) | 12 months | Any repeat revascularization (percutaneous or surgical) of the target lesion performed for recurrent symptoms or objective evidence of ischemia attributable to the target lesion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device-Oriented Composite Endpoint (DOCE) | 12 months | Composite of cardiac death, target-vessel myocardial infarction, and clinically-driven target lesion revascularization. |
| Target Vessel Revascularization (TVR) | 12 months | Any repeat revascularization (percutaneous or surgical) of the target vessel. |
| All-cause Mortality | 12 months | Death from any cause during the study follow-up period. |
| Cardiac Death | 12 months | Death attributed to cardiovascular causes, including death from unknown cause. |
| Target-Vessel Myocardial Infarction (TV-MI) | 12 months | Myocardial infarction attributable to the target vessel based on clinical, electrocardiographic, and biomarker criteria according to the Fourth Universal Definition of Myocardial Infarction. |
| Any Myocardial Infarction | 12 months | Any myocardial infarction (target-vessel or non-target-vessel) according to the Fourth Universal Definition of Myocardial Infarction. |
Contacts
CONTACTFilippo Gurguglione
CONTACTBeatrice Barbano
PRINCIPAL_INVESTIGATORFilippo Luca Gurgoglione
A.O.U. di Parma
Outcome results
None listed