Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
Study NCT ID:
NCT03780192
Status:
UNKNOWN
Last Update Posted:
2020-03-17
First Post:
2018-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
INSPIRON Sirolimus Eluting Stent Performance in Bifurcation Coronary Arteries Treated Using Provisional Technique
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': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2022-02-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-16', 'studyFirstSubmitDate': '2018-12-17', 'studyFirstSubmitQcDate': '2018-12-17', 'lastUpdatePostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Stenosis', 'timeFrame': 'day 0', 'description': '% of stenosis on side branch after stent placement on main vessel'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bifurcation Lesion', 'Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Evaluate the efficacy of the Inspiron Sirolimus Eluting Stent on bifurcation coronary artery lesions, in order to preserve and not compromize the side branch using the provisional stent technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with bifurcation coronary artery disease with indication for drug eluting implantation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with coronary artery disease on bifurcation anatomy with indication of drug eluting stent implantation , on which the side branch is ≥ 2.5 mm diameter and ostial stenosis ≤50% (Medina 1-1-0, 1-0-0, 0-1-0).\n\nExclusion Criteria:\n\n* Acute Myocardial Infarction (STMI);\n* Chronic occlusion;\n* Cardiogenic shock;\n* Ejection fraction ≤ 20%;\n* Thrombocytopenia (≤ 50 mil);\n* DAPT contraindication;\n* Life expectancy of less than 12 months.'}, 'identificationModule': {'nctId': 'NCT03780192', 'acronym': 'insProvisional', 'briefTitle': 'INSPIRON Sirolimus Eluting Stent Performance in Bifurcation Coronary Arteries Treated Using Provisional Technique', 'organization': {'class': 'INDUSTRY', 'fullName': 'Scitech Produtos Medicos Ltda'}, 'officialTitle': 'INSPIRON Sirolimus Eluting Stent Performance in Bifurcation Coronary Arteries Treated Using Provisional Technique', 'orgStudyIdInfo': {'id': 'SC-INS-001-2019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment', 'description': 'Bifurcation lesion treatment using provisional stent technique', 'interventionNames': ['Device: Inspiron Sirolimus Eluting Stent']}], 'interventions': [{'name': 'Inspiron Sirolimus Eluting Stent', 'type': 'DEVICE', 'description': 'Bifurcation treatment using provisional stent technique', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Marco Wainstein, MD', 'role': 'CONTACT', 'email': 'marco.wainstein@hmv.org.br'}, {'name': 'Marco W Wainstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Moinhos de Vento', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'centralContacts': [{'name': 'Marco Wainstein, MD', 'role': 'CONTACT', 'email': 'marco.wainstein@hmv.org.br', 'phone': '+555133143537'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scitech Produtos Medicos Ltda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator Hospital Moinhos de Vento', 'investigatorFullName': 'Marco Vugman Wainstein', 'investigatorAffiliation': 'Scitech Produtos Medicos Ltda'}}}}