Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:50 AM
Study NCT ID:
NCT07390994
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-05
First Post:
2026-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The PICCOLETO IX PHENO Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-04-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-29', 'studyFirstSubmitDate': '2026-01-29', 'studyFirstSubmitQcDate': '2026-01-29', 'lastUpdatePostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinically-driven Target Lesion Revascularization (TLR)', 'timeFrame': '12 months', 'description': 'Any repeat revascularization (percutaneous or surgical) of the target lesion performed for recurrent symptoms or objective evidence of ischemia attributable to the target lesion.'}], 'secondaryOutcomes': [{'measure': 'Device-Oriented Composite Endpoint (DOCE)', 'timeFrame': '12 months', 'description': 'Composite of cardiac death, target-vessel myocardial infarction, and clinically-driven target lesion revascularization.'}, {'measure': 'Target Vessel Revascularization (TVR)', 'timeFrame': '12 months', 'description': 'Any repeat revascularization (percutaneous or surgical) of the target vessel.'}, {'measure': 'All-cause Mortality', 'timeFrame': '12 months', 'description': 'Death from any cause during the study follow-up period.'}, {'measure': 'Cardiac Death', 'timeFrame': '12 months', 'description': 'Death attributed to cardiovascular causes, including death from unknown cause.'}, {'measure': 'Target-Vessel Myocardial Infarction (TV-MI)', 'timeFrame': '12 months', 'description': 'Myocardial infarction attributable to the target vessel based on clinical, electrocardiographic, and biomarker criteria according to the Fourth Universal Definition of Myocardial Infarction.'}, {'measure': 'Any Myocardial Infarction', 'timeFrame': '12 months', 'description': 'Any myocardial infarction (target-vessel or non-target-vessel) according to the Fourth Universal Definition of Myocardial Infarction.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug-Coated Balloon', 'Optical Coherence Tomography', 'Percutaneous Coronary Intervention', 'Plaque phenotype'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic coronary syndrome or acute coronary syndrome diagnosis (per ESC guidelines).\n* 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.\n* OCT assessment of the target segment phenotype prior to lesion preparation and DCB angioplasty.\n* Successful DCB angioplasty according to DCB ARC criteria.\n* Patients who underwent DCB-only PCI, or hybrid DCB-DES PCI with at least 20 mm of the target segment treated with DCB.\n\nExclusion Criteria:\n\n* Previous revascularization of the target segment with stent.\n* 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.\n* Lack of at least 6 months of clinical follow up.\n* PCI of chronic total occlusion.'}, 'identificationModule': {'nctId': 'NCT07390994', 'acronym': 'PIX-PHENO', 'briefTitle': 'The PICCOLETO IX PHENO Study', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Ricerca e Innovazione Cardiovascolare ETS'}, 'officialTitle': 'Prognostic Impact of PHENOtyping de Novo Coronary Artery Disease Prior to Drug-Coated Balloon Angioplasty by Optical Coherence Tomography (PICCOLETO IX PHENO)', 'orgStudyIdInfo': {'id': 'PICCOLETO IX - PHENO'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Filippo Gurguglione', 'role': 'CONTACT', 'email': 'mailto:filippolucagurgoglione@gmail.com', 'phone': '+393312048150'}, {'name': 'Beatrice Barbano', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Filippo Luca Gurgoglione', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A.O.U. di Parma'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Ricerca e Innovazione Cardiovascolare ETS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}