Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-11 @ 9:28 AM
Study NCT ID:
NCT00232804
Status:
COMPLETED
Last Update Posted:
2007-10-10
First Post:
2005-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The BRIDGE Registry: Safety and Efficacy Registry of Bx Cypher 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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 639}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2004-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-10-08', 'studyFirstSubmitDate': '2005-10-04', 'studyFirstSubmitQcDate': '2005-10-04', 'lastUpdatePostDateStruct': {'date': '2007-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MACE.', 'timeFrame': '1, 6, and 12 months post-procedure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '15291158', 'type': 'RESULT', 'citation': 'Lablanche JM, Commeau P; Investigateurs du Registre BRIDGE. [BRIDGE registry (safety and efficacy registry Bx Cyper stent in the RevascularIzation of patients with siGnificative risk of rEstenosis): protocol description and preliminary results]. Ann Cardiol Angeiol (Paris). 2004 May;53 Suppl 1:29s-31s. doi: 10.1016/s0003-3928(04)90006-6. No abstract available. French.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to establish the safety and efficacy of the treatment with Cypher DES in diabetic patients with documented ischemia due to stenosis (small coronary artery 2.5 -3 mm in lumen diameter, with lesion between 15 mm 30 mm in length, ) in native coronary arteries.\n\nThe objective of this study is to document that the use of Cypher DES in these diabetic patients undergoing percutaneous revascularization for stenosis is safe.\n\nSafety will be assessed over a period of 12 months.', 'detailedDescription': 'This is a prospective, multicenter, comparative, non randomised, open registry of 1000 patients who will be followed up to 12 months at 100 sites in France.\n\nPatients will be screened according to normal practice and in relation to the inclusion and exclusion criteria. Patients should have a documented ischemia related to the target vessel.\n\nProcedure of stent placement should be done under existing in hospital procedural protocol and care should be taken to follow Cordis instructions as set forth in the Instructions For Use.\n\nFollow up will be done according to normal procedure and the minimum should be a telephone contact at 1, 6 and 12 months.\n\nAll data gathered during the enrollment, procedure, follow up and when specific events to the patient may occur, will be entered into the Internet CRF form, by the treating physician or a person from his staff specifically appointed to this task.\n\nPatient enrollment is anticipated to last 8 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. NIDDM treated with oral antidiabetics for at least 3 months, or IDDM treated for at least 3 months with documented HbA1C;\n2. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B I-II) OR patients with documented silent ischemia;\n3. Target lesion stenosis is \\>50% (visual estimate);\n4. Target vessel diameter, between 2.5 and 3.0 mm\n5. Target lesion length minimum 15 mm and maximum 30mm\n\nExclusion Criteria:\n\n1. CK and CK-MB enzymes above normal or elevated troponin level (as determined by site criteria) at the time of treatment;\n2. Has unstable angina classified as Braunwald III B and A or C I-II-III, or is having a peri-infarction;\n3. Unprotected left main coronary disease with \\>=50% stenosis;\n4. Significant (\\>50%) stenosis proximal or distal to the target lesion that might impede inflow or runoff and can not be revascularized before or during the index procedure;\n5. Have an ostial target lesion;\n6. Documented left ventricular ejection fraction \\<=30%;\n7. In-Stent restenosis;\n8. Chronic total occlusion.'}, 'identificationModule': {'nctId': 'NCT00232804', 'briefTitle': 'The BRIDGE Registry: Safety and Efficacy Registry of Bx Cypher Stent', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cordis US Corp.'}, 'officialTitle': 'Safety and Efficacy Registry of Bx Cypher Stent in the Revascularisation of Patients With Significant Risk of Restenosis', 'orgStudyIdInfo': {'id': '01290402'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'interventionNames': ['Device: Bx Cypher stent']}], 'interventions': [{'name': 'Bx Cypher stent', 'type': 'DEVICE', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Université de Lille, Hôpital cardiologique', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Lablanche, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Lille, Hôpital cardiologique'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cordis US Corp.', 'class': 'INDUSTRY'}}}}