The PICCOLETO IX PHENO Study

NCT07390994 | Not Yet Recruiting

• 1 other identifier: PICCOLETO IX - PHENO
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease

Keywords

Drug-Coated Balloon; Optical Coherence Tomography; Percutaneous Coronary Intervention; Plaque phenotype

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Device-Oriented Composite Endpoint (DOCE)

  12 months

• Target Vessel Revascularization (TVR)

  12 months

• All-cause Mortality

  12 months

• Cardiac Death

  12 months

• Target-Vessel Myocardial Infarction (TV-MI)

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Ricerca e Innovazione Cardiovascolare ETS: lead

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Filippo Luca Gurgoglione

  A.O.U. di Parma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Filippo Gurguglione

CONTACT

+393312048150; mailto:filippolucagurgoglione@gmail.com

Beatrice Barbano

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 5, 2026
• Study Start: January 9, 2026
• Primary Completion (Estimated): March 10, 2027
• Study Completion (Estimated): April 20, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-01