Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 10:09 PM
Study NCT ID:
NCT00888758
Status:
UNKNOWN
Last Update Posted:
2009-05-01
First Post:
2009-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Biolimus A9 and Everolimus Drug-Eluting Stents in Patients With ST Segment Elevation Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2011-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-04-30', 'studyFirstSubmitDate': '2009-04-27', 'studyFirstSubmitQcDate': '2009-04-27', 'lastUpdatePostDateStruct': {'date': '2009-05-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "to compare a safety and effectiveness of third generation DES (biolimus A9 and everolimus) in patients with STEMI treated by primary PCI with OCT guidance with assessment of a MACE's at 9 month follow-up", 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'number of uncovered stent struts', 'timeFrame': '2 years'}, {'measure': 'number of malaposed stents struts', 'timeFrame': '2 years'}, {'measure': 'in-stent neointimal volume', 'timeFrame': '2 years'}, {'measure': 'in-segment assessment of vessel wall response to DES', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Stents'], 'conditions': ['Coronary Heart Disease', 'Percutaneous Coronary Intervention']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is:\n\n* comparison of a safety and effectiveness of third generation DES (biolimus A9 and everolimus) in patients with STEMI treated by primary PCI with OCT guidance. A rate of 9 month MACE (deaths, myocardial infarction, ischemia driven TLR) will be assessed in both groups.\n\nThe secondary outcomes are a comparison of (using OCT):\n\n* number of uncovered stent struts\n* number of malapposed stents struts\n* in-stent neointimal volume\n* in-segment assessment of vessel wall response to DES', 'detailedDescription': 'The aim of this multicenter, prospective, randomized trial with a core lab analysis is to assess the safety and effectiveness (at 9-month follow-up) of third generation DES (biolimus A9 and everolimus) in patients with evolving STEMI with the OCT guidance (to optimize a stent implantation) A serial OCT analysis will be performed to assess the number of either uncovered or malaposed stents strut and a degree of in-stent neointimal hyperplasia. Furthermore, the in-segment vessel wall response to DES implantation will also be analysed. The goal is to enroll 400 patients (200 in each group) with OCT guidance in 100 patients in each group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Acute STEMI within 12 hours from symptoms onset\n2. Native coronary disease with a lesion suitable for stenting\n3. Vessel size in between 2.5-3.75mm\n4. Patient is willing to provide written informed consent\n5. Male or female patients between 18-85 years of age\n\nExclusion Criteria:\n\n1. Significant left main disease\n2. Killip class IV\n3. Known allergy to aspirin and or clopidogrel/ticlopidine\n4. Recent bleeding (\\<1month)\n5. Patient in anticoagulant therapy\n6. No suitable coronary anatomy for OCT scan (ostial lesion, very distal or large vessel /\\>3.75mm in diameter/)\n7. Pregnancy\n8. Severe liver or renal disease (Cr\\>2.0)\n9. Life expectancy \\< 1 year'}, 'identificationModule': {'nctId': 'NCT00888758', 'acronym': 'ROBUST', 'briefTitle': 'Comparison of Biolimus A9 and Everolimus Drug-Eluting Stents in Patients With ST Segment Elevation Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Masaryk University'}, 'officialTitle': 'Randomized Comparison of Biolimus-Eluting and Everolimus-Eluting Stents With Optical Coherence Tomography Guided Stent Implantation in ST Elevation Myocardial Infarction.A 9-Month Angiographic and Optical Coherence Tomography Follow-up.', 'orgStudyIdInfo': {'id': '06042006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Device: biolimus A9']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Device: everolimus']}], 'interventions': [{'name': 'biolimus A9', 'type': 'DEVICE', 'otherNames': ['biolimus A9 eluting stent'], 'description': '200 patients with STEMI will be treated using Biomatrix stent.', 'armGroupLabels': ['1']}, {'name': 'everolimus', 'type': 'DEVICE', 'otherNames': ['everolimus eluting stent'], 'description': '200 patients with STEMI will be treated with PROMUS DES.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40113', 'city': 'Ústí nad Labem', 'country': 'Czechia', 'contacts': [{'name': 'Pavel Cervinka, MD,PhD', 'role': 'CONTACT', 'email': 'pavel.cervinka@mnul.cz', 'phone': '+420477117886'}, {'name': 'Petr Kala, MD,P hD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ladislav Pesl, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Cardiology, Masaryk hospital and University of JEP', 'geoPoint': {'lat': 50.6607, 'lon': 14.03227}}], 'centralContacts': [{'name': 'Pavel Cervinka, MD,PhD', 'role': 'CONTACT', 'email': 'pavel.cervinka@mnul.cz', 'phone': '+420477117886'}], 'overallOfficials': [{'name': 'Pavel Cervinka, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Krajska zdravotni a.s., Masarzk hospital Usti nad Labem'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masaryk University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Assoc. prof. Pavel Červinka, MD, PhD, FESC, FSCAI', 'oldOrganization': 'Masaryk hospital and University of JEP Ústí nad Labem'}}}}