The PICCOLETO IX PHENO Study (PIX-PHENO)

Prognostic Impact of PHENOtyping de Novo Coronary Artery Disease Prior to Drug-Coated Balloon Angioplasty by Optical Coherence Tomography (PICCOLETO IX PHENO)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease

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.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Filippo Gurguglione; Phone Number: +393312048150; Email: mailto:filippolucagurgoglione@gmail.com
• Study Contact Backup: Name: Beatrice Barbano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with chronic coronary syndrome or acute coronary syndrome who underwent drug-coated balloon angioplasty for de novo obstructive coronary artery disease with preprocedural optical coherence tomography assessment of the target segment.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device-Oriented Composite Endpoint (DOCE)	Composite of cardiac death, target-vessel myocardial infarction, and clinically-driven target lesion revascularization.	12 months
Target Vessel Revascularization (TVR)	Any repeat revascularization (percutaneous or surgical) of the target vessel.	12 months
All-cause Mortality	Death from any cause during the study follow-up period.	12 months
Cardiac Death	Death attributed to cardiovascular causes, including death from unknown cause.	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.	12 months
Any Myocardial Infarction	Any myocardial infarction (target-vessel or non-target-vessel) according to the Fourth Universal Definition of Myocardial Infarction.	12 months

Collaborators and Investigators

• Sponsor: Fondazione Ricerca e Innovazione Cardiovascolare ETS
• Investigators: Principal Investigator: Filippo Luca Gurgoglione, A.O.U. di Parma

Study record dates

Study Major Dates

• Study Start (Estimated): January 9, 2026
• Primary Completion (Estimated): March 10, 2027
• Study Completion (Estimated): April 20, 2027

Study Registration Dates

• First Submitted: January 29, 2026
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Drug-Coated Balloon; Optical Coherence Tomography; Plaque phenotype
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: PICCOLETO IX - PHENO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data may be made available to qualified researchers upon reasonable request after study completion and primary publication, subject to appropriate data use agreements and ethics committee approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No