Ignite Creation Date:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2025-12-25 @ 7:21 PM
Study NCT ID:
NCT00799032
Status:
COMPLETED
Last Update Posted:
2017-06-07
First Post:
2008-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The ATLANTA First in Man Study of the Catania Stent
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': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-06', 'studyFirstSubmitDate': '2008-11-25', 'studyFirstSubmitQcDate': '2008-11-26', 'lastUpdatePostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedural success, Target Lesion Revascularization, Target Vessel Revascularization, Stent Thrombosis, Cardiac death, fatal/non fatal MI', 'timeFrame': 'In Hospital'}], 'secondaryOutcomes': [{'measure': 'Any death, cardiac death, stent related fatal / non fatal Myocardial Infarction, Target Lesion Revascularization, Target Vessel Revascularization, Stent Thrombosis, Binary Restenosis', 'timeFrame': '1 and 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Coronary Stent'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'To evaluate the short-term and mid-term safety and efficacy of the Catania coronary stent for the treatment of up to two de novo lesions in native coronary arteries.', 'detailedDescription': 'This is a prospective, non-randomized, first-in-man single center study. The study requires a 55 patients with documented myocardial ischemia undergoing PCI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lesion length ≤ 20 mm\n* Vessel size ≥ 2.5 ≤ 3.5 mm\n\nExclusion Criteria:\n\n* Life expectancy \\< 1 year\n* Left ventricular ejection fraction (LVEF) \\<30%\n* Anti-thrombotic drug intolerance'}, 'identificationModule': {'nctId': 'NCT00799032', 'acronym': 'ATLANTA', 'briefTitle': 'The ATLANTA First in Man Study of the Catania Stent', 'organization': {'class': 'INDUSTRY', 'fullName': 'CeloNova BioSciences, Inc.'}, 'officialTitle': 'Assessment of The Latest Non-Thrombogenic Angioplasty Stent (ATLANTA): Prospective, First in Man, Non-Randomized, Single Center for Patients With Documented Myocardial Ischemia Undergoing PCI', 'orgStudyIdInfo': {'id': 'CL-PC-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Stent', 'description': 'Catania Stent', 'interventionNames': ['Device: PCI']}], 'interventions': [{'name': 'PCI', 'type': 'DEVICE', 'otherNames': ['Catania Stent'], 'description': 'coronary stent implantation', 'armGroupLabels': ['Stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95124', 'city': 'Catania', 'state': 'Sicily', 'country': 'Italy', 'facility': 'Ferrarotto Hospital', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}], 'overallOfficials': [{'name': 'Corrado Tamburino, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ferrarotto Hospital, University of Catania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CeloNova BioSciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Corrado Tamburino, MD, PhD', 'oldOrganization': 'Ferrarotto Hospital, University of Catania'}}}}