Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 2:42 PM
Study NCT ID:
NCT01060306
Status:
WITHDRAWN
Last Update Posted:
2020-02-24
First Post:
2010-02-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optical Coherence Tomography Evaluation of a Biodegradable Polymer-based Drug-eluting Stent
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Funding issues', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2011-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-21', 'studyFirstSubmitDate': '2010-02-01', 'studyFirstSubmitQcDate': '2010-02-01', 'lastUpdatePostDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of neointimal coverage of the biodegradable polymer-based Biolimus A9-eluting stent (Biomatrix stent) after full drug elution and polymer biodegradation', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Assessment of neointimal coverage of the biodegradable polymer-based Biolimus A9-eluting stent (Biomatrix stent) one month after full drug elution and polymer biodegradation', 'timeFrame': '7 months'}, {'measure': 'Comparison of neointimal coverage of the biodegradable polymer-based Biolimus A9-eluting stent (Biomatrix stent) one month after full drug elution and polymer biodegradation and of its bare metal stent counterpart (Gazelle) one month after implantation', 'timeFrame': '7 months'}, {'measure': 'Comparison of the neointimal coverage of the biodegradable polymer-based Biolimus A9-eluting stent (Biomatrix stent) after full drug elution and polymer biodegradation (6 months) and at one month after this time-point (7 months)', 'timeFrame': '7 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'PONTINA aims at assessing by optical coherence tomography the neointimal coverage of the biodegradable polymer-based Biolimus A9-eluting stent (Biomatrix stent) after full drug elution and polymer biodegradation (6 months), at one month after this time-point (7 months) and, as a comparator, of its bare metal stent counterpart (Gazelle stent) at 1 month after implantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with stable or unstable coronary artery disease undergoing percutaneous coronary intervention on the left anterior descending artery with a Biomatrix stent placement or on the left circumflex artery with a Gazelle stent placement', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>50 years\n* de novo lesion\n* lesion length \\<24 mm\n* reference vessel diameter 3 mm\n\nExclusion Criteria:\n\n* low compliance to dual antiplatelet therapy\n* life expectancy \\<1 year\n* allergy to any drug or substance use prior, during or after percutaneous coronary intervention\n* chronic renal insufficiency\n* low left ventricle ejection fraction (\\<35%)\n* recent acute myocardial infarction\n* previous coronary intervention\n* off-label indication to stenting\n* participation in another investigation\n* refusal to participate to the study'}, 'identificationModule': {'nctId': 'NCT01060306', 'acronym': 'PONTINA', 'briefTitle': 'Optical Coherence Tomography Evaluation of a Biodegradable Polymer-based Drug-eluting Stent', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale Santa Maria Goretti'}, 'officialTitle': 'Prospective Optical cohereNce Tomography Evaluation of neoINtimal Coverage of a biodegrAdable Polymer-based Drug-eluting Stent', 'orgStudyIdInfo': {'id': 'SMG-005'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bare metal stent 1 month', 'description': 'Patients implanted with the bare metal stent Gazelle evaluated for neointimal coverage one month after implantation'}, {'label': 'Biodegradable polymer stent 6 months', 'description': 'Patients implanted with the biodegradable polymer-based Biolimus A9-eluting stent (Biomatrix stent) evaluated for neointimal coverage after full drug elution and polymer biodegradation (6 months)'}, {'label': 'Biodegradable polymer stent 7 months', 'description': 'Patients implanted with the biodegradable polymer-based Biolimus A9-eluting stent (Biomatrix stent) evaluated for neointimal coverage one month after full drug elution and polymer biodegradation (7 months)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '04100', 'city': 'Latina', 'country': 'Italy', 'facility': 'UOC Emodinamica e Cardiologia Interventistica - Ospedale Santa Maria Goretti', 'geoPoint': {'lat': 41.46614, 'lon': 12.9043}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale Santa Maria Goretti', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Gregory Sgueglia, MD', 'investigatorAffiliation': 'Ospedale Santa Maria Goretti'}}}}