The PICCOLETO IX PHENO Study

N/ANot Yet RecruitingNCT07390994

Fondazione Ricerca e Innovazione Cardiovascolare ETS600 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Coronary Artery Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Clinically-driven Target Lesion Revascularization (TLR)

Any repeat revascularization (percutaneous or surgical) of the target lesion performed for recurrent symptoms or objective evidence of ischemia attributable to the target lesion.

Time frame: 12 months

Secondary Outcomes

Device-Oriented Composite Endpoint (DOCE)

Composite of cardiac death, target-vessel myocardial infarction, and clinically-driven target lesion revascularization.

Time frame: 12 months

Target Vessel Revascularization (TVR)

Any repeat revascularization (percutaneous or surgical) of the target vessel.

Time frame: 12 months

All-cause Mortality

Death from any cause during the study follow-up period.

Time frame: 12 months

Cardiac Death

Death attributed to cardiovascular causes, including death from unknown cause.

Time frame: 12 months

Target-Vessel Myocardial Infarction (TV-MI)

Myocardial infarction attributable to the target vessel based on clinical, electrocardiographic, and biomarker criteria according to the Fourth Universal Definition of Myocardial Infarction.

Time frame: 12 months

Any Myocardial Infarction

Any myocardial infarction (target-vessel or non-target-vessel) according to the Fourth Universal Definition of Myocardial Infarction.

Time frame: 12 months

Central Contacts

Filippo Gurguglione

CONTACT

+393312048150 mailto:filippolucagurgoglione@gmail.com

Beatrice Barbano

CONTACT

Data from ClinicalTrials.gov

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