Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT00233818
Status:
COMPLETED
Last Update Posted:
2007-10-12
First Post:
2005-10-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FIM-NL - First-in-Man Study (Netherlands Part) With Sirolimus Coated Modified 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': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2005-06', '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': '11686669', 'type': 'RESULT', 'citation': 'Rensing BJ, Vos J, Smits PC, Foley DP, van den Brand MJ, van der Giessen WJ, de Feijter PJ, Serruys PW. Coronary restenosis elimination with a sirolimus eluting stent: first European human experience with 6-month angiographic and intravascular ultrasonic follow-up. Eur Heart J. 2001 Nov;22(22):2125-30. doi: 10.1053/euhj.2001.2892.'}, {'pmid': '12270850', 'type': 'RESULT', 'citation': 'Degertekin M, Serruys PW, Foley DP, Tanabe K, Regar E, Vos J, Smits PC, van der Giessen WJ, van den Brand M, de Feyter P, Popma JJ. Persistent inhibition of neointimal hyperplasia after sirolimus-eluting stent implantation: long-term (up to 2 years) clinical, angiographic, and intravascular ultrasound follow-up. Circulation. 2002 Sep 24;106(13):1610-3. doi: 10.1161/01.cir.0000034447.02535.d5.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the performance and safety of a formulation of the antiproliferative agent, sirolimus coated on modified Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor Over The Wire (OTW) Stent Delivery System (SDS) in patients with de novo coronary artery lesions.', 'detailedDescription': 'This is a single center, non-randomized study. Patients who meet the eligibility criteria will be treated with the sirolimus coated modified Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor OTW SDS. Patients will be followed for five years post-procedure, with all patients having a repeat angiography at 6 months, 18 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 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': 'NCT00233818', 'briefTitle': 'FIM-NL - First-in-Man Study (Netherlands Part) With Sirolimus Coated Modified BX Velocity Stent', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cordis US Corp.'}, 'officialTitle': 'An Evaluation of Sirolimus-Coated Modified BX VELOCITY Balloon-Expandable Stents for the Treatment of Patients With de Novo Native Coronary Artery Lesions', 'orgStudyIdInfo': {'id': 'EC99-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'interventionNames': ['Device: Sirolimus-coated Bx VELOCITY Stent']}], 'interventions': [{'name': 'Sirolimus-coated Bx VELOCITY Stent', 'type': 'DEVICE', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NL- 3015 GD', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus Centrum Thoraxcentrum', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'overallOfficials': [{'name': 'Patrick W Serruys, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasmus Centrum Thoraxcentrum'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cordis US Corp.', 'class': 'INDUSTRY'}}}}