Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-03-01 @ 9:55 PM
Study NCT ID:
NCT03103620
Status:
COMPLETED
Last Update Posted:
2018-08-07
First Post:
2017-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness Evaluation of COBRA PzF Coronary Stent System: A Post Marketing Observational Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060050', 'term': 'Angina, Stable'}, {'id': 'D000789', 'term': 'Angina, Unstable'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}, {'id': 'D000072658', 'term': 'Non-ST Elevated Myocardial Infarction'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1027}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-06', 'studyFirstSubmitDate': '2017-03-31', 'studyFirstSubmitQcDate': '2017-03-31', 'lastUpdatePostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MACE', 'timeFrame': '12 months', 'description': 'Composite clinical endpoint of cardiac death, myocardial infarction, and clinically driven target lesion revascularization'}], 'secondaryOutcomes': [{'measure': 'Stent thrombosis', 'timeFrame': '12 months', 'description': 'Stent thrombosis (according to ARC definition)'}, {'measure': 'TVR and TLR', 'timeFrame': '12 months', 'description': 'Target vessel and lesion revascularization'}, {'measure': 'DAPT', 'timeFrame': '12 months', 'description': 'Mean length of dual antiplatelet therapy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stable Angina', 'Unstable Angina', 'ACS - Acute Coronary Syndrome', 'STEMI', 'NSTEMI - Non-ST Segment Elevation MI', 'Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'A multi-center, prospective, consecutive enrolled, observational registry. The population being studied includes all patients undergoing treatment of "de novo" lesions in native coronary vessels, saphenous vein graft and/or arterial bypass conduits with the COBRA PzF coronary stent system. The registry will primarily assess the rate of MACE (cardiac death, myocardial infarction and clinically driven target lesion revascularization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients undergoing treatment of "de novo" lesions in native coronary vessels, saphenous vein graft and/or arterial bypass conduits with the COBRA PzF coronary stent system', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatient has given oral consent to participate in the registry Patient is implanted with a COBRA PzF stent Target lesion(s) is/are "de novo"\n\nExclusion Criteria:\n\nPregnancy Age \\<18 years Refusal or inability to give oral consent'}, 'identificationModule': {'nctId': 'NCT03103620', 'acronym': 'eCOBRA', 'briefTitle': 'Safety and Effectiveness Evaluation of COBRA PzF Coronary Stent System: A Post Marketing Observational Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'CeloNova BioSciences, Inc.'}, 'officialTitle': 'Safety And Effectiveness Evaluation Of COBRA PzF™ Coronary Stent System: A French Observational Postmarketing Registry', 'orgStudyIdInfo': {'id': 'COBRA 2013-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'COBRA PzF Coronary Stent System', 'type': 'DEVICE', 'description': 'COBRA PzF Coronary Stent System'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aix', 'country': 'France', 'facility': 'Clinique Axium', 'geoPoint': {'lat': 45.61604, 'lon': 2.38255}}, {'city': 'Annecy', 'country': 'France', 'facility': 'GCS Cardio', 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'city': 'Antony', 'country': 'France', 'facility': 'SCM Angioscan', 'geoPoint': {'lat': 48.75329, 'lon': 2.29668}}, {'city': 'Aubagne', 'country': 'France', 'facility': 'Clinique La Casamance', 'geoPoint': {'lat': 43.29276, 'lon': 5.57067}}, {'city': 'Avignon', 'country': 'France', 'facility': 'Centre Hospitalier', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'city': 'Bayonne', 'country': 'France', 'facility': 'Clinique La Fourcade', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'city': 'Brivé', 'country': 'France', 'facility': 'Centre Hospitalier', 'geoPoint': {'lat': 47.48857, 'lon': -2.00321}}, {'city': 'Clermont', 'country': 'France', 'facility': 'Clinique des Domes', 'geoPoint': {'lat': 49.37897, 'lon': 2.41258}}, {'city': 'Évecquemont', 'country': 'France', 'facility': 'Clinique Cardiologie', 'geoPoint': {'lat': 49.01439, 'lon': 1.94425}}, {'city': 'Grenoble', 'country': 'France', 'facility': 'Clinique Mutualiste', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Haguenau', 'country': 'France', 'facility': 'Centre Hospitalier', 'geoPoint': {'lat': 48.81557, 'lon': 7.79051}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Infirmerie Protestante', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Montauban', 'country': 'France', 'facility': 'Clinique du Pont de Chaume', 'geoPoint': {'lat': 44.01759, 'lon': 1.3542}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'Clinique du Millenaire', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Pau', 'country': 'France', 'facility': 'Centre Hospitalier', 'geoPoint': {'lat': 43.31117, 'lon': -0.35583}}, {'city': 'Pessac', 'country': 'France', 'facility': 'Clinique St-Martin', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'city': 'Reims', 'country': 'France', 'facility': 'Polyclinique de Courlancy', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Rouen', 'country': 'France', 'facility': 'Clinique St Hilaire', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'overallOfficials': [{'name': 'Luc Maillard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique Axium'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CeloNova BioSciences, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'AlpinARC', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}