Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2026-01-26 @ 1:41 AM
Study NCT ID:
NCT03269461
Status:
COMPLETED
Last Update Posted:
2020-09-04
First Post:
2017-08-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serial OCT Evaluation of Tissue Coverage in Patients Submitted to Inspiron Drug Eluting Stent Implantation
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'}, {'id': 'D020163', 'term': 'Ornithine Carbamoyltransferase Deficiency 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'}, {'id': 'D056806', 'term': 'Urea Cycle Disorders, Inborn'}, {'id': 'D020739', 'term': 'Brain Diseases, Metabolic, Inborn'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D000592', 'term': 'Amino Acid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000792', 'term': 'Angiography'}], 'ancestors': [{'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-03', 'studyFirstSubmitDate': '2017-08-24', 'studyFirstSubmitQcDate': '2017-08-30', 'lastUpdatePostDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tissue Coverage', 'timeFrame': '3 months', 'description': 'Change in the tissue coverage percentage measured by OCT'}], 'secondaryOutcomes': [{'measure': 'in-stent late lumen loss', 'timeFrame': '3 months', 'description': 'in-stent late lumen loss'}, {'measure': 'Stent Thrombosis', 'timeFrame': '2 years', 'description': 'Stent Thrombosis Rates'}, {'measure': 'Target Vessel Failure', 'timeFrame': '2 years', 'description': 'Target Vessel Failure (Death, MI and new revascularization)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stent, DES, INSPIRON, OCT, tissue repair'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Prospective, multicentric, single-arm study to evaluate fast and effective tissue repair in patients undergone percutaneous coronary intervention with drug eluting stent Inspiron.', 'detailedDescription': 'The first 20 patients enrolled will be evaluated by angiography and Optical Coherence Tomography 3 months after stent implantation. The following 20 patients will be evaluated by the same methods 2 months after the implantation and the last 20 patients after 30 days.\n\nAll patients will be clinically followed at 30 days, 6 months, 1 and 2 years after index procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 and ≤ 80years;\n* Symptomatic CAD or documented myocardial ischemic disease;\n* Up to 2 de novo lesions on native coronary arteries;\n* Lesion length ≤ 29mm;\n* Reference vessel diameter between ≥2.5 and ≤ 3.5 mm;\n* Stenose at target lesion ≥ 70% and ≤ 99%.\n\nExclusion Criteria:\n\n* STEMI within the last 72 hours pre-procedure;\n* renal insufficiency;\n* Left Main stenosis \\> 50%;\n* Ostial lesions;\n* Bifurcation lesions with side branch ≥2mm;\n* More than one lesion \\> 50% at the target vessel;\n* Left Ejection Fraction less than 30%;\n* Previous (less than 6 months) PCI at the target vessel.'}, 'identificationModule': {'nctId': 'NCT03269461', 'acronym': 'REPAIR', 'briefTitle': 'Serial OCT Evaluation of Tissue Coverage in Patients Submitted to Inspiron Drug Eluting Stent Implantation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Scitech Produtos Medicos Ltda'}, 'officialTitle': 'Serial OCT Evaluation of Tissue Coverage in Patients Submitted to Inspiron Drug Eluting Stent Implantation', 'orgStudyIdInfo': {'id': 'REPAIR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '30 days evaluation', 'description': 'Angiography and Optical Coherence Tomography evaluations', 'interventionNames': ['Device: Angiography and Optical Coherence Tomography evaluations']}, {'type': 'EXPERIMENTAL', 'label': '2 months evaluation', 'description': 'Angiography and Optical Coherence Tomography evaluations', 'interventionNames': ['Device: Angiography and Optical Coherence Tomography evaluations']}, {'type': 'EXPERIMENTAL', 'label': '3 months evaluation', 'description': 'Angiography and Optical Coherence Tomography evaluations', 'interventionNames': ['Device: Angiography and Optical Coherence Tomography evaluations']}], 'interventions': [{'name': 'Angiography and Optical Coherence Tomography evaluations', 'type': 'DEVICE', 'description': 'coronary stent implantation followed by Angiography and Optical Coherence Tomography evaluations', 'armGroupLabels': ['2 months evaluation', '3 months evaluation', '30 days evaluation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vila Velha', 'state': 'Espírito Santo', 'country': 'Brazil', 'facility': 'Hospital Evangélico do Espírito Santo', 'geoPoint': {'lat': -20.32972, 'lon': -40.2925}}, {'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'facility': 'Hospital do Coração Anis Rassi', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'city': 'Maringá', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Paraná Medical Research Center', 'geoPoint': {'lat': -23.42528, 'lon': -51.93861}}, {'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Instituto de Cardiologia do Rio Grande do Sul', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto Dante Pazzanese de Cardiologia', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scitech Produtos Medicos Ltda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}