Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-27 @ 9:26 PM
Study NCT ID:
NCT03327961
Status:
RECRUITING
Last Update Posted:
2024-12-12
First Post:
2017-10-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Scaffold in Emilia Romagna and in the MAGIC Network
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1111}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2034-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-07', 'studyFirstSubmitDate': '2017-10-27', 'studyFirstSubmitQcDate': '2017-10-27', 'lastUpdatePostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device Oriented Cardiac Events', 'timeFrame': '1 year', 'description': 'cumulative occurence of cardiovascular death, target vessel myocardial infarction and target vessel revascularization. Target is defined the vessel treated with scaffold'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The prospective study will investigate the clinical performance and long-term safety of scaffold implantation in a real world regional setting. The protocol includes two different networks. The first network includes all cath-labs in the Emilia-Romagna region (SHERPA). The second includes the centers partecipating into the MAGIC retrospective study. Both networks joined into the prospective SHERPA-MAGIC project. Investigators from both networks agreed in indications and strategy implanatation described by the protocol. In each center, after IRB approval, the patients will be enrolled according to established criteria.', 'detailedDescription': 'Coronary stents are the default devices for the treatment of coronary artery disease in percutaneous coronary intervention (PCI) according to existing guidelines. However, thrombosis and restenosis are still the main limitations of current permanent metallic stents. In contrast to Bare Metal Stents (BMSs), Drug Eluting Stents (DESs) have a reduced restenosis rate due to the presence of antiproliferative agents in the coating layer of the stent surface and reduced rate of repeat revascularisation. However, late and very late stent thrombosis remains the limitation of DES in spite of prolonged dual antiplatelet therapy. Bioabsorbable scaffolds have been introduced to overcome limitations of permanent metallic stents.\n\nThe aim of this observational prospective study is to investigate the clinical performance and long-term safety of scaffold in a real world regional setting.\n\nThe investigators agreed in the following preferential/optimal indications:\n\n* complete revascularization in patients with age \\<65 years\n* revascularization of long lesions (\\>24 mm), especially located in left anterior descending\n* spontaneous coronary dissection\n\nThe investigators agreed in the following strategy implantation:\n\n* mandatory predilatation\n* sizing 1:1\n* to avoid vessel with reference vessel diameter \\<2.8 mm and \\>3.8 mm\n* to avoid vessel with severe calcifications\n* mandatory postdilation with non compliant balloon ≥0.5 the scaffold diameter\n\nThe study organization is based on:\n\nDATA SAFETY MONITORING BOARD (DSMB) All adverse events will be reported to the DSMB and reviewed on an on-going basis throughout the subject enrolment and follow-up period to ensure the safety of subjects enrolled in this study. The DSMB may request additional information as needed.\n\nCORE LABORATORY ANALYSIS All coronary artery angiographies and percutaneous coronary interventions will be reviewed by an indipendent core-lab. The core-lab will perform quantitative coronary analysis and assessment of the agreement between implantation technique in each case and established criteria'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with symptomatic coronary artery disease needing the treatment of de novo native coronary artery lesions.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects \\>18 years\n* sign of the patients informed consent\n* implanation of at least one scaffold\n\nExclusion Criteria:\n\n* inability to garantuee at least one year follow-up\n* inabiliuty to garantuee at least one year compliance to dual antiplatelet regimen'}, 'identificationModule': {'nctId': 'NCT03327961', 'acronym': 'SHERPA-MAGIC', 'briefTitle': 'Scaffold in Emilia Romagna and in the MAGIC Network', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Ferrara'}, 'officialTitle': 'Scaffold Implantation in Emilia-Romagna Plus Multi Absorbable Gears Intra Coronary', 'orgStudyIdInfo': {'id': '170899'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'scaffold', 'description': 'Patients receiving during PCI the implantation of at least one scaffold', 'interventionNames': ['Device: scaffold']}], 'interventions': [{'name': 'scaffold', 'type': 'DEVICE', 'description': 'implantation of scaffold (eg Magmaris, Desolve, Others)', 'armGroupLabels': ['scaffold']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Agrigento', 'state': 'Agrigento', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Salvatore Geraci', 'role': 'CONTACT'}], 'facility': 'AO San Giovanni di Dio', 'geoPoint': {'lat': 37.31065, 'lon': 13.57661}}, {'city': 'Treviglio', 'state': 'Bergamo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paolo Sganzerla', 'role': 'CONTACT'}], 'facility': 'Ospedale Caravaggio-Treviglio', 'geoPoint': {'lat': 45.52081, 'lon': 9.59102}}, {'city': 'Bologna', 'state': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesco Saia, MD', 'role': 'CONTACT'}], 'facility': 'Azienda Ospedaliera Universitaria di Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Bologna', 'state': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gianni Casella, MD', 'role': 'CONTACT'}], 'facility': 'U.O. Cardiologia, Ospedale Maggiore', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Savigliano', 'state': 'Cuneo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Baldassarre Doronzo', 'role': 'CONTACT'}], 'facility': 'Ospedale SS Annunziata', 'geoPoint': {'lat': 44.64808, 'lon': 7.65677}}, {'zip': '44124', 'city': 'Cona', 'state': 'Ferrara', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Simone Biscaglia, MD', 'role': 'CONTACT', 'email': 'bscsmn@unife.it', 'phone': '+390532239883'}, {'name': 'Gianluca Campo, MD', 'role': 'CONTACT'}, {'name': 'Matteo Tebaldi, MD', 'role': 'CONTACT'}, {'name': 'Carlo Tumscitz, MD', 'role': 'CONTACT'}, {'name': 'Simone Biscaglia, MD', 'role': 'CONTACT'}], 'facility': 'University Hospital of Ferrara', 'geoPoint': {'lat': 44.80583, 'lon': 11.7069}}, {'city': 'Forlì', 'state': 'Forlì-Cesena', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Fabio Tarantino, MD', 'role': 'CONTACT'}], 'facility': 'U.O. Cardiologia, Ospedale Morgagni Pierantoni', 'geoPoint': {'lat': 44.22177, 'lon': 12.04144}}, {'city': 'Modena', 'state': 'Modena', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Fabio Sgura', 'role': 'CONTACT'}], 'facility': 'U.O. Cardiologia, Azienda Ospedaliera Universitaria di Modena, Policlinico', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'city': 'Modena', 'state': 'Modena', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Daniele Iaccarino, MD', 'role': 'CONTACT'}], 'facility': 'U.O. Cardiologia, Ospedale di Baggiovara', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'city': 'Parma', 'state': 'Parma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alberto Menozzi, MD', 'role': 'CONTACT'}], 'facility': 'U.O. di Cardiologia, Azienda Ospedaliero-Universitaria di Parma', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'city': 'Piacenza', 'state': 'Piacenza', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luciano Losi, MD', 'role': 'CONTACT'}], 'facility': 'Ospedale Guglielmo da Saliceto', 'geoPoint': {'lat': 45.05242, 'lon': 9.69342}}, {'city': 'Cotignola', 'state': 'Ravenna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paolo Sbarzaglia, MD', 'role': 'CONTACT'}], 'facility': 'Maria Cecilia Hospital - GVM Care & Research', 'geoPoint': {'lat': 44.38572, 'lon': 11.93852}}, {'city': 'Ravenna', 'state': 'Ravenna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marco Balduccelli, MD', 'role': 'CONTACT'}], 'facility': 'U.O. di Cardiologia, Ospedale Santa Maria delle Croci', 'geoPoint': {'lat': 44.41344, 'lon': 12.20121}}, {'city': 'Rimini', 'state': 'Rimini', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Andrea Santarelli, MD', 'role': 'CONTACT'}], 'facility': 'U.O. di Cardiologia, Ospedale degli Infermi', 'geoPoint': {'lat': 44.05755, 'lon': 12.56528}}, {'city': 'Orbassano', 'state': 'Torino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Enrico Cerrato', 'role': 'CONTACT'}], 'facility': 'AOU San Luigi Gonzaga', 'geoPoint': {'lat': 45.00547, 'lon': 7.53813}}, {'city': 'Rivoli', 'state': 'Torino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Fernando Varbella', 'role': 'CONTACT'}], 'facility': 'Ospedale di Rivoli', 'geoPoint': {'lat': 45.07073, 'lon': 7.51465}}, {'city': 'Sanremo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Massimo Leoncini', 'role': 'CONTACT'}], 'facility': 'Ospedale di Sanremo', 'geoPoint': {'lat': 43.81725, 'lon': 7.7772}}], 'centralContacts': [{'name': 'Veronica Lodolini', 'role': 'CONTACT', 'email': 'ldlvnc@unife.it', 'phone': '0532236450', 'phoneExt': '+39'}, {'name': 'Elisa Mosele', 'role': 'CONTACT', 'email': 'elisa21mosele@gmail.com', 'phone': '0532236450', 'phoneExt': '+39'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Ferrara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Gianluca Campo', 'investigatorAffiliation': 'University Hospital of Ferrara'}}}}