Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-26 @ 1:12 AM
Study NCT ID:
NCT03471234
Status:
COMPLETED
Last Update Posted:
2023-05-18
First Post:
2018-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Latin America Real World Study With Inspiron Drug Eluting Stent - INSPIRON LATITUDE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017130', 'term': 'Angioplasty'}], 'ancestors': [{'id': 'D002404', 'term': 'Catheterization'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 299}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-17', 'studyFirstSubmitDate': '2018-03-05', 'studyFirstSubmitQcDate': '2018-03-19', 'lastUpdatePostDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MACE (major cardiac events)', 'timeFrame': '12 months', 'description': 'Major cardiac events (death, myocardial infarction, target vessel revascularization)'}], 'secondaryOutcomes': [{'measure': 'Acute success', 'timeFrame': 'up to 24 hours', 'description': 'Acute success measured by Angiography after stent implantation'}, {'measure': 'Stent Thrombosis', 'timeFrame': '24 months', 'description': 'Stent Thrombosis rate'}, {'measure': 'MACE', 'timeFrame': '24 months', 'description': 'Major cardiac events (death, myocardial infarction, target vessel revascularization)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['coronary disease', 'drug eluting stent', 'Inspiron'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Prospective, multicenter, single arm registry to monitor post-market clinical outcomes of patients treated with Inspiron Sirolimus-Eluting Stent with Biodegradable Polymer.', 'detailedDescription': 'Prospective, multicenter, single arm registry to assess the safety and performance of Inspiron Sirolimus-Eluting Stent with Biodegradable Polymer for the treatment of "real world" patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with lesions in native coronary arteries measuring between 2.5 and 4.0 mm in diameter and 34 mm length treated only with Inspiron Sirolimus-Eluting Stent.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All individuals aged over 18 years who signed the informed consent and had lesions in native coronary arteries treated only with Inspiron Sirolimus-Eluting stent.\n\nExclusion Criteria:\n\n* Saphenous vein grafts or Mammary lesions;\n* Individuals who have been treated within the last 6 months with another stent;\n* Acute myocardial infarction with ST segment elevation;\n* Chronic Total Occlusion'}, 'identificationModule': {'nctId': 'NCT03471234', 'acronym': 'LATITUDE', 'briefTitle': 'Latin America Real World Study With Inspiron Drug Eluting Stent - INSPIRON LATITUDE', 'organization': {'class': 'INDUSTRY', 'fullName': 'Scitech Produtos Medicos Ltda'}, 'officialTitle': 'LATIn American sTUdy to Investigate the Clinical Performance of Sirolimus-eluting Stent With Abluminal-only bioDEgradable Polymeric Coating (Inspiron TM) in the Treatment of Native Coronary Artery Lesions.', 'orgStudyIdInfo': {'id': 'SCI-CO-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Angioplasty', 'type': 'DEVICE', 'description': 'Inspiron Drug Eluting stent implantation'}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto Dante Pazzanese de Cardiologia', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto do Coração - INCOR', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scitech Produtos Medicos Ltda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}