Coronary Artery DiseasePIX-PHENONCT07390994
The PICCOLETO IX PHENO Study
An observational study of Coronary Artery Disease, run by Fondazione Ricerca e Innovazione Cardiovascolare ETS.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 9 Jan 2026to 20 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Beatrice Barbano contact
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Keywords
- Drug-Coated Balloon, Optical Coherence Tomography, Percutaneous Coronary Intervention, Plaque phenotype
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (6)
Device-Oriented Composite Endpoint (DOCE)
Composite of cardiac death, target-vessel myocardial infarction, and clinically-driven target lesion revascularization.
Measured: 12 months
Target Vessel Revascularization (TVR)
Any repeat revascularization (percutaneous or surgical) of the target vessel.
Measured: 12 months
All-cause Mortality
Death from any cause during the study follow-up period.
Measured: 12 months
Cardiac Death
Death attributed to cardiovascular causes, including death from unknown cause.
Measured: 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.
Measured: 12 months
Any Myocardial Infarction
Any myocardial infarction (target-vessel or non-target-vessel) according to the Fourth Universal Definition of Myocardial Infarction.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start9 Jan 2026 (estimated)
- Primary completion10 Mar 2027 (estimated)
- Study completion20 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Ricerca e Innovazione Cardiovascolare ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Filippo Luca Gurgoglione, Principal investigator, A.O.U. di Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390994
- Sponsor's protocol ID
- PICCOLETO IX - PHENO
- Acronym
- PIX-PHENO
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Impact of PHENOtyping de Novo Coronary Artery Disease Prior to Drug-Coated Balloon Angioplasty by Optical Coherence Tomography (PICCOLETO IX PHENO)
- ClinicalTrials.gov ID
- NCT07390994
- Acronym / sponsor ID
- PIX-PHENO / PICCOLETO IX - PHENO
- Conditions
- Coronary Artery Disease
- Keywords
- Drug-Coated Balloon, Optical Coherence Tomography, Percutaneous Coronary Intervention, Plaque phenotype
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fondazione Ricerca e Innovazione Cardiovascolare ETSUniversity, hospital or other
- Study start
- 9 Jan 2026 (estimated)
- Primary completion
- 10 Mar 2027 (estimated)
- Study completion
- 20 Apr 2027 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinically-driven Target Lesion Revascularization (TLR)
Time frame: 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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Beatrice Barbano contact
Filippo Luca Gurgoglione principal investigator
A.O.U. di Parma
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Fondazione Ricerca e Innovazione Cardiovascolare ETS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Filippo Gurguglione (+393312048150, mailto:filippolucagurgoglione@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically-driven Target Lesion Revascularization (TLR) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.