Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2026-03-31 @ 12:01 PM
Study NCT ID:
NCT00596661
Status:
COMPLETED
Last Update Posted:
2008-10-15
First Post:
2008-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The TRIMAXX Coronary Stent Trial
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': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-10-10', 'studyFirstSubmitDate': '2008-01-09', 'studyFirstSubmitQcDate': '2008-01-16', 'lastUpdatePostDateStruct': {'date': '2008-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Adverse Cardiac Events(MACE). MACE defined as Cardiac Death, MI(Q-wave and Non Q-wave) and Rarget Vessel Revascularization (TVR)', 'timeFrame': '30 Days'}], 'secondaryOutcomes': [{'measure': 'Clinical Outcome: MACE', 'timeFrame': '6 months'}, {'measure': 'Clinical Outcome: Ischemia driven TVR', 'timeFrame': '6 months'}, {'measure': 'Clinical Outcome: Ischemia driven Target LesionRevascularization(TLR)', 'timeFrame': '6 months'}, {'measure': 'Clinical Outcome: Target Vessel Failure(TVF)', 'timeFrame': '6 months'}, {'measure': 'Angiographic Outcome: Device Success defined as achievment of a final residual in-stent stenosis > 30%(by QCA) using the assigned device only', 'timeFrame': 'procedural'}, {'measure': 'Angiographic Outcome: Lesion Success defined as attainment of a >30% residual in-stent stenosis (by QCA) using any percutaneous method', 'timeFrame': 'procedural'}, {'measure': 'Angiographic Outcome: Procedural Success without the occurrence of cardiac death, Q-wave or Non Q-wave MI or repeat revascularization of the target lesion during the hospital stay.', 'timeFrame': 'hospital stay'}, {'measure': 'Angiographic Outcome: Angiographic in-stent and in-segment binary restenosis rate(>/= 50% diameter stenosis)', 'timeFrame': 'at 6 months'}, {'measure': 'Angiographic Outcome: In-stent, in-segment, proximal, and distal minimum lumen diameter(MLD))', 'timeFrame': 'at 6 months'}, {'measure': 'Angiographic Outcome: Angiographic in-stent late loss, defined as the difference between the post-procedural MLD and the follow-up MLD', 'timeFrame': 'at 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['coronary stent'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '18044791', 'type': 'RESULT', 'citation': 'Abizaid A, Popma JJ, Tanajura LF, Hattori K, Solberg B, Larracas C, Feres F, Costa Jde R Jr, Schwartz LB. Clinical and angiographic results of percutaneous coronary revascularization using a trilayer stainless steel-tantalum-stainless steel phosphorylcholine-coated stent: the TriMaxx trial. Catheter Cardiovasc Interv. 2007 Dec 1;70(7):914-9. doi: 10.1002/ccd.21279.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the trial is to demonstrate the safety and feasibility of treating coronary artery lesions which have not been previously treated with the TRIMAXX Coronary stent system as compared to the reported results for commercially available non-drug eluting coronary stent systems which are indicated for the same treatments.', 'detailedDescription': 'The TriMaxx study is a prospective, multicenter, non-randomized, single-arm trial intended to demonstrate the safety and feasibility of the TriMaxx Cornary Stent System. The study will enroll 100 subjects with de novo native coronary artery lesions who meet the eligibility criteria and agree to participate in the study. Subjects will be enrolled in a sequential manner. The safety and feasibility of the TRIMAXX stent will be evaluated by comparing the MACE rate that is observed 30 days post-procedure to the MACE rate for commercially available non-drug eluting stents. Secoandry evaluations will include analysis of clinical and angiographic parameters at 6 months. All subjects will undergo assessments at 30 days and at 6 months. Additionally, all subjects will undergo a follow-up angiogram at 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible for catheter based treatment\n* Single coronary lesion requiring treatment\n* Lesion is accessible with stent device\n* Completes informed consent for participation\n* Stable condition (no symptoms of heart attack within 72 hours prior to treatment)\n\nExclusion Criteria:\n\n* Normal lab values\n* Previous treatment in the affected artery'}, 'identificationModule': {'nctId': 'NCT00596661', 'briefTitle': 'The TRIMAXX Coronary Stent Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'A Prospective, Multi-Center, Non-Randomized, Single-Arm Trial to Evaluate the Safety and Feasibility of the TriMaxx Coronary Stent in de Novo Coronary Artery Lesions.', 'orgStudyIdInfo': {'id': 'AVD 640-0051-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TRIMAXX', 'description': 'TRIMAXX Coronary Stent', 'interventionNames': ['Device: TriMaxx Coronary Stent placement']}], 'interventions': [{'name': 'TriMaxx Coronary Stent placement', 'type': 'DEVICE', 'otherNames': ['TriMaxx™ Coronary Stent'], 'description': 'Angioplasty with coronary artery stent placement', 'armGroupLabels': ['TRIMAXX']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto Dante Pazzanese de Cardiologia', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Uberlândia', 'country': 'Brazil', 'facility': 'Instituto Do Coracao do Triangolo Mineiro', 'geoPoint': {'lat': -18.91861, 'lon': -48.27722}}, {'city': 'Mainz', 'country': 'Germany', 'facility': 'Johannes Gutenberg Universitat', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}], 'overallOfficials': [{'name': 'Alexandre Abizaid, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Dante Pazzanese de Cardioloigia, Sao Paulo, Brazil'}, {'name': 'Jeffery J Popma, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital. Boston, Massachusetts, USA"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Matt Kiely, Manager Medical Information', 'oldOrganization': 'Abbott Vascular'}}}}