Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-09 @ 7:52 PM
Study NCT ID:
NCT00233792
Status:
COMPLETED
Last Update Posted:
2007-10-12
First Post:
2005-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FIM-BR - First-in-Man Study (Brazil Part) With Sirolimus-Coated BX VELOCITY 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', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-10-11', 'studyFirstSubmitDate': '2005-10-04', 'studyFirstSubmitQcDate': '2005-10-05', 'lastUpdatePostDateStruct': {'date': '2007-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of in-stent percent diameter stenosis (%DS) measured by quantitative coronary angiography.', 'timeFrame': 'post procedure and 6 months'}], 'secondaryOutcomes': [{'measure': 'Assessment of lesion morphology by intravascular ultrasound (IVUS).', 'timeFrame': 'post procedure and 6 months'}, {'measure': 'Target vessel failure (TVF).', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '12551858', 'type': 'RESULT', 'citation': 'Sousa JE, Costa MA, Sousa AG, Abizaid AC, Seixas AC, Abizaid AS, Feres F, Mattos LA, Falotico R, Jaeger J, Popma JJ, Serruys PW. Two-year angiographic and intravascular ultrasound follow-up after implantation of sirolimus-eluting stents in human coronary arteries. Circulation. 2003 Jan 28;107(3):381-3. doi: 10.1161/01.cir.0000051720.59095.6d.'}, {'pmid': '15851603', 'type': 'RESULT', 'citation': 'Sousa JE, Costa MA, Abizaid A, Feres F, Seixas AC, Tanajura LF, Mattos LA, Falotico R, Jaeger J, Popma JJ, Serruys PW, Sousa AG. Four-year angiographic and intravascular ultrasound follow-up of patients treated with sirolimus-eluting stents. Circulation. 2005 May 10;111(18):2326-9. doi: 10.1161/01.CIR.0000164271.01172.1A. Epub 2005 Apr 25.'}, {'pmid': '16256867', 'type': 'RESULT', 'citation': 'Aoki J, Abizaid AC, Serruys PW, Ong AT, Boersma E, Sousa JE, Bruining N. Evaluation of four-year coronary artery response after sirolimus-eluting stent implantation using serial quantitative intravascular ultrasound and computer-assisted grayscale value analysis for plaque composition in event-free patients. J Am Coll Cardiol. 2005 Nov 1;46(9):1670-6. doi: 10.1016/j.jacc.2005.06.076. Epub 2005 Oct 10.'}, {'pmid': '11208675', 'type': 'RESULT', 'citation': 'Sousa JE, Costa MA, Abizaid A, Abizaid AS, Feres F, Pinto IM, Seixas AC, Staico R, Mattos LA, Sousa AG, Falotico R, Jaeger J, Popma JJ, Serruys PW. Lack of neointimal proliferation after implantation of sirolimus-coated stents in human coronary arteries: a quantitative coronary angiography and three-dimensional intravascular ultrasound study. Circulation. 2001 Jan 16;103(2):192-5. doi: 10.1161/01.cir.103.2.192.'}]}, 'descriptionModule': {'briefSummary': 'This is a single center, non-randomized study. Patients will be treated with the sirolimus coated Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor OTW SDS. Patients will have a repeat angiography at four months and will be followed for twelve months post-procedure.', 'detailedDescription': 'This is a single center, non-randomized study of the Bx VELOCITY Balloon-Expandable Stent coated with sirolimus (140µg/cm2) and formulated for fast or slow release. The sirolimus coated stent is mounted on the Raptor OTW SDS. Approximately 30 patients with de novo or restenotic native coronary artery lesions \\<=18mm in length and \\>=3.0 to \\>=3.5 mm in diameter by visual estimate who meet all eligibility criteria will be treated with the sirolimus coated Bx VELOCITY stent(s). Patients will be followed for five years post-procedure and will have a repeat angiography at 4 months, 12 months, 24 months, and 48 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS) or a positive ischemia study;\n2. Single de novo or restenotic lesion requiring treatment in a major native coronary artery;\n3. Target lesion is \\<=18mm in length (visual estimate);\n4. Target lesion is \\>=3.0mm and \\<=3.5mm in diameter (visual estimate);\n5. Target lesion stenosis is \\>50% and \\<100% (visual estimate);\n\nExclusion Criteria:\n\n1. A Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal;\n2. Unprotected left main coronary disease with \\>=50% stenosis;\n3. Have an ostial target lesion;\n4. Angiographic evidence of thrombus within target lesion;\n5. Calcified lesions which cannot be successfully predilated;\n6. Ejection fraction \\<=30%;\n7. Target lesion involves bifurcation (either stenosis of both main vessel and major branch or stenosis of just major branch);\n8. Totally occluded vessel;'}, 'identificationModule': {'nctId': 'NCT00233792', 'briefTitle': 'FIM-BR - First-in-Man Study (Brazil Part) With Sirolimus-Coated BX VELOCITY Stent', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cordis US Corp.'}, 'officialTitle': 'An Evaluation of the Sirolimus Coated Modified BX VELOCITY Balloon-Expandable Stent in the Treatment of Patients With de Novo or Restenotic Native Coronary Artery Lesions.', 'orgStudyIdInfo': {'id': 'P99-6301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'sirolimus coated Bx VELOCITY stent - fast release', 'interventionNames': ['Device: sirolimus coated Bx VELOCITY stent - fast release']}, {'type': 'OTHER', 'label': '2', 'description': 'sirolimus coated Bx VELOCITY stent - slow release', 'interventionNames': ['Device: sirolimus coated Bx VELOCITY stent - slow release']}], 'interventions': [{'name': 'sirolimus coated Bx VELOCITY stent - fast release', 'type': 'DEVICE', 'armGroupLabels': ['1']}, {'name': 'sirolimus coated Bx VELOCITY stent - slow release', 'type': 'DEVICE', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04012-909', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto Dante Pazzanese of Cardiology', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Eduardo J Sousa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Dante Pazzanese of Cardiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cordis US Corp.', 'class': 'INDUSTRY'}}}}