Ignite Creation Date:
2025-12-25 @ 4:34 AM
Ignite Modification Date:
2025-12-26 @ 3:36 AM
Study NCT ID:
NCT03899818
Status:
COMPLETED
Last Update Posted:
2019-04-02
First Post:
2019-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054855', 'term': 'Drug-Eluting Stents'}], 'ancestors': [{'id': 'D015607', 'term': 'Stents'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-01', 'studyFirstSubmitDate': '2019-02-19', 'studyFirstSubmitQcDate': '2019-04-01', 'lastUpdatePostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Verify the non-inferiority of DCB', 'timeFrame': 'up to 6 months', 'description': 'the primary objective of the study is the non-inferiority of the DCB compared to DES in terms of absence of restenosis, defined as reoccurrence of stenoses of at least 50% of the lumen of the vessel at angiographic follow-up (6 months after surgery).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with changes of vessels lumen', 'timeFrame': 'up to 12 months', 'description': 'any differences between groups in terms of vascular changes to angiography.'}, {'measure': 'Concentration in blood chemistry', 'timeFrame': 'up to 6 months', 'description': 'changes of concentration in blood chemistry between the groups'}, {'measure': 'Number of Participants with adverse events', 'timeFrame': 'up to 12 months', 'description': 'appearance of major cardiovascular adverse events'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['small vessels', 'drug coated balloon'], 'conditions': ['Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '39718036', 'type': 'DERIVED', 'citation': 'Fezzi S, Trevisanello A, Buccheri D, Borgi M, Orrego PS, Zoccai GB, Cortese B. Physiological Performance of Drug-Coated Balloons in Small Coronary Arteries PICCOLETO II muFR. Catheter Cardiovasc Interv. 2025 Feb;105(3):643-649. doi: 10.1002/ccd.31376. Epub 2024 Dec 24.'}, {'pmid': '37164603', 'type': 'DERIVED', 'citation': 'Cortese B, Testa G, Rivero F, Erriquez A, Alfonso F. Long-Term Outcome of Drug-Coated Balloon vs Drug-Eluting Stent for Small Coronary Vessels: PICCOLETO-II 3-Year Follow-Up. JACC Cardiovasc Interv. 2023 May 8;16(9):1054-1061. doi: 10.1016/j.jcin.2023.02.011. Epub 2023 Apr 19.'}, {'pmid': '33248978', 'type': 'DERIVED', 'citation': 'Cortese B, Di Palma G, Guimaraes MG, Piraino D, Orrego PS, Buccheri D, Rivero F, Perotto A, Zambelli G, Alfonso F. Drug-Coated Balloon Versus Drug-Eluting Stent for Small Coronary Vessel Disease: PICCOLETO II Randomized Clinical Trial. JACC Cardiovasc Interv. 2020 Dec 28;13(24):2840-2849. doi: 10.1016/j.jcin.2020.08.035. Epub 2020 Nov 25.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, multicentre, randomized clinical study of consecutive patients with coronary artery disease in vessels with diameter ≤2.75 mm. Patients will be randomized to drug-eluting balloon (DEB) or standard therapy with second generation drug-eluting stent (DES). Study population will consist of 240 patients with stable or unstable angina'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Age \\>18 years.\n2. Stable or unstable coronary artery disease.\n3. Native coronary artery lesion in vessel with diameter \\<2.75 mm.\n4. Clinical indication to percutaneous coronary intervention (PCI).\n\nExclusion criteria\n\n1. Enrolment in another study with any investigational drug or device.\n2. Acute or recent (≤48 hours) myocardial infarction.\n3. Creatinine clearance \\<50 ml/min.\n4. Left ventricle ejection fraction \\<30%.\n5. Any known allergy, hypersensitivity or intolerance to any drug used during or after the procedure.\n6. Heavily calcified and severely tortuous lesions.'}, 'identificationModule': {'nctId': 'NCT03899818', 'acronym': 'PICCOLETO II', 'briefTitle': 'Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Fatebenefratelli and Ophthalmic Hospital'}, 'officialTitle': 'Impiego Del Pallone Medicato Per il Trattamento di Piccoli Vasi Coronarici in Confronto Con Stent Medicato - Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment', 'orgStudyIdInfo': {'id': 'PICCOLETO2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'new generation DEB', 'description': 'drug-eluting balloon (DEB)', 'interventionNames': ['Device: drug-eluting balloon']}, {'type': 'OTHER', 'label': 'second generation DES', 'description': 'standard therapy with second generation drug-eluting stent (DES)', 'interventionNames': ['Device: drug-eluting stent']}], 'interventions': [{'name': 'drug-eluting balloon', 'type': 'DEVICE', 'description': 'Patients will be randomized to drug-eluting balloon (DEB) or standard therapy with second generation drug-eluting stent (DES)', 'armGroupLabels': ['new generation DEB']}, {'name': 'drug-eluting stent', 'type': 'DEVICE', 'description': 'Patients will be randomized to drug-eluting balloon (DEB) or standard therapy with second generation drug-eluting stent (DES).', 'armGroupLabels': ['second generation DES']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fatebenefratelli and Ophthalmic Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, A.O. Fatebenefratelli Milano, Italy', 'investigatorFullName': 'Bernardo Cortese', 'investigatorAffiliation': 'Fatebenefratelli and Ophthalmic Hospital'}}}}