Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2026-01-07 @ 2:29 AM
Study NCT ID:
NCT00235092
Status:
COMPLETED
Last Update Posted:
2007-04-27
First Post:
2005-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The REALITY Study - Head-to-Head Comparison Between Cypher and Taxus
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 1335}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'completionDateStruct': {'date': '2006-03'}, 'lastUpdateSubmitDate': '2007-04-25', 'studyFirstSubmitDate': '2005-10-04', 'studyFirstSubmitQcDate': '2005-10-07', 'lastUpdatePostDateStruct': {'date': '2007-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint of the study is angiographic in-lesion binary restenosis rate at 8 months follow-up as determined by QCA.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '16493102', 'type': 'RESULT', 'citation': 'Morice MC, Colombo A, Meier B, Serruys P, Tamburino C, Guagliumi G, Sousa E, Stoll HP; REALITY Trial Investigators. Sirolimus- vs paclitaxel-eluting stents in de novo coronary artery lesions: the REALITY trial: a randomized controlled trial. JAMA. 2006 Feb 22;295(8):895-904. doi: 10.1001/jama.295.8.895.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to compare the performance of the Cypher sirolimus-eluting and the Taxus paclitaxel-eluting stent systems in a prospective, multi-center, randomized clinical study.', 'detailedDescription': 'This is a prospective, randomized study conducted at 90 centers in Europe, Latin-America and Asia. A total of 1335 patients will be entered into the study and will be randomized on a 1:1 basis to either the sirolimus-eluting or the paclitaxel-eluting stent system. All patients will have repeat angiography at eight months and will be followed for 24 months post-procedure.'}, '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 I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\\&C, I-II-III) OR patients with documented silent ischemia;\n2. Treatment of up to two de novo native coronary artery lesions in a maximum of two major coronary arteries;\n3. Ostial lesions;\n4. Bifurcations;\n5. Target vessel diameter of both lesions must be \\>=2.25mm and \\<=3.0mm in diameter (visual estimate);\n6. One target lesion must be at least 15 mm in length and the second lesion has to be at least 10 mm in length with no upper limit on either;\n7. Target lesion stenosis for both lesions is \\>50% and \\<100% (visual estimate).\n\nExclusion Criteria:\n\n1. Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK \\>2 times normal within the preceding 72 hours and the CK and CK-MB enzymes remain above normal at the time of treatment;\n2. Has unstable angina classified as Braunwald A I-II-III;\n3. Any of the lesions is an unprotected left main coronary disease with \\>=50% stenosis;\n4. Angiographic evidence of thrombus within target lesion;\n5. Heavily calcified lesion and/or calcified lesion, which cannot be successfully predilated (applies to both lesions);\n6. Documented left ventricular ejection fraction \\<=25%;\n\n8\\. Totally occluded vessel (TIMI 0 level) (applies to both lesions);\n\n9\\. Prior stent within 10mm of target lesion (applies to both lesions).'}, 'identificationModule': {'nctId': 'NCT00235092', 'briefTitle': 'The REALITY Study - Head-to-Head Comparison Between Cypher and Taxus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cordis US Corp.'}, 'officialTitle': 'A Prospective, Randomized, Multi-Center Comparison of the Cypher Sirolimus-Eluting and the Taxus Paclitaxel-Eluting Stent Systems.', 'orgStudyIdInfo': {'id': 'EC03-02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cypher Sirolimus-Eluting Stent', 'type': 'DEVICE'}, {'name': 'Taxus Paclitaxel-Eluting Stent', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Massy', 'country': 'France', 'facility': 'Institut Hospitalier Jacques Cartier', 'geoPoint': {'lat': 48.72692, 'lon': 2.28301}}], 'overallOfficials': [{'name': 'Marie-Claude Morice, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Hospitalier Jacques Cartier'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cordis US Corp.', 'class': 'INDUSTRY'}}}}