Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-03-05 @ 12:18 AM
Study NCT ID:
NCT03263260
Status:
COMPLETED
Last Update Posted:
2024-09-04
First Post:
2017-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-marketing Registry of Inspiron Sirolimus Eluting Coronary Stent
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'C535731', 'term': 'Dysequilibrium syndrome'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016254', 'term': 'Mutagenesis, Insertional'}], 'ancestors': [{'id': 'D015202', 'term': 'Protein Engineering'}, {'id': 'D005818', 'term': 'Genetic Engineering'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D009154', 'term': 'Mutation'}, {'id': 'D014644', 'term': 'Genetic Variation'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D016296', 'term': 'Mutagenesis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2504}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-01-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-02', 'studyFirstSubmitDate': '2017-08-24', 'studyFirstSubmitQcDate': '2017-08-24', 'lastUpdatePostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Adverse Cardiac Events Rate', 'timeFrame': '12 months', 'description': 'Cardiac Death, MI, Target Lesion Revascularization and Stent Thrombosis'}], 'secondaryOutcomes': [{'measure': 'Target Vessel and Lesion Revascularization Rates', 'timeFrame': '24 months', 'description': 'Target Vessel and Lesion Revascularization'}, {'measure': 'Stent Thrombosis Rate', 'timeFrame': '24 months', 'description': 'Stent Thrombosis'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stent, DES, Inspiron'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Post-marketing, prospective, multicentric, non-randomized registry to evaluate the safety and efficacy of Inspiron Sirolimus Eluting Coronary Stent at the treatment of "real-world" patients.', 'detailedDescription': 'Up to 5.0000 patients with native coronary arteries lesions with diameter between 2.5 and 4.0 mm and 34 mm of length treated solely with the Inspiron Sirolimus Eluting Coronary Stent.\n\nStent implantation should be performed according to the Instructions for Use and according to the local practice. It is recommended that ECG and cardiac enzymes are collected before and after procedure. Dual anti-platelet therapy is recommended for at least 6 months after procedure.\n\nPatients will be followed at 30 days, 1 and 2 years after procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients older than 18 years submitted to implant of the Inspiron Sirolimus Eluting Stent in native coronary arteries', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* alll patients that have been treated with the Inspiron Sirolimus Eluting Stent older and 18 years\n\nExclusion Criteria:\n\n* Safein Vein or Left Internal Mammary artery Grafts'}, 'identificationModule': {'nctId': 'NCT03263260', 'acronym': 'Inspiron RL II', 'briefTitle': 'Post-marketing Registry of Inspiron Sirolimus Eluting Coronary Stent', 'organization': {'class': 'INDUSTRY', 'fullName': 'Scitech Produtos Medicos Ltda'}, 'officialTitle': 'Prospective, Multicentric, Post-marketing Registry of Inspiron Sirolimus Eluting Coronary Stent for Treatment of Patients With Native Coronary Artery Lesions (Inspiron Real Life II)', 'orgStudyIdInfo': {'id': 'Inspiron RL II'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'implanted patients', 'description': 'Patients with native coronary artery lesions with diameter between 2.5 and 4.0 and 34 mm of length treated only with the Inspiron Sirolimus eluting Stent', 'interventionNames': ['Device: implant']}], 'interventions': [{'name': 'implant', 'type': 'DEVICE', 'description': 'coronary stent implantation', 'armGroupLabels': ['implanted patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90.619-900', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'União Brasileira de Educação e Assistência - Hospital São Lucas da PUC - RS', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scitech Produtos Medicos Ltda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}