Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-19 @ 11:37 PM
Study NCT ID:
NCT00476957
Status:
COMPLETED
Last Update Posted:
2014-11-10
First Post:
2007-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized Study Comparing Endeavor With Cypher Stents (PROTECT)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015607', 'term': 'Stents'}], 'ancestors': [{'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'frank.van.leeuwen@medtronic.com', 'phone': '+31 43 3566622', 'title': 'Dr. Frank van Leeuwen, Director Clinical Research Coronary and Renal Denervation', 'organization': 'Medtronic Bakken Research Center'}, 'certainAgreement': {'otherDetails': 'For any publication or presentation of the Protected Materials or any portion thereof, a manuscript of the paper, abstract or other materials will be provided by Consultant to Sponsor for its approval at least sixty (60) days for manuscripts and thirty (30) days for presentations prior to outside submission. Medtronic shall have the right to request reasonable modifications of any manuscript or other materials to be published or presented.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'E-ZES', 'description': 'Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System\n\nStent : Stent implantation', 'otherNumAtRisk': 4357, 'otherNumAffected': 201, 'seriousNumAtRisk': 4357, 'seriousNumAffected': 579}, {'id': 'EG001', 'title': 'C-SES', 'description': 'Cordis Cypher® Sirolimus-eluting Coronary Stent\n\nStent : Stent implantation', 'otherNumAtRisk': 4352, 'otherNumAffected': 184, 'seriousNumAtRisk': 4352, 'seriousNumAffected': 507}], 'otherEvents': [{'term': 'Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4357, 'numEvents': 201, 'numAffected': 201}, {'groupId': 'EG001', 'numAtRisk': 4352, 'numEvents': 184, 'numAffected': 184}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'MACCE (major adverse cardiac and cerebrovascular event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4357, 'numEvents': 579, 'numAffected': 579}, {'groupId': 'EG001', 'numAtRisk': 4352, 'numEvents': 507, 'numAffected': 507}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '4.6'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'To Compare Overall Definite or Probable Stent Thrombosis Rate of the Endeavor® Zotarolimus Eluting Coronary Stent System Versus the Cypher® Sirolimus-eluting Coronary Stent in a Patient Population Requiring Stent Implantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4357', 'groupId': 'OG000'}, {'value': '4352', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E-ZES', 'description': 'Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System\n\nStent : Stent implantation'}, {'id': 'OG001', 'title': 'C-SES', 'description': 'Cordis Cypher® Sirolimus-eluting Coronary Stent\n\nStent : Stent implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'Definite or probable stent thrombosis rate.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4357', 'groupId': 'OG000'}, {'value': '4352', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E-ZES', 'description': 'Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System\n\nStent : Stent implantation'}, {'id': 'OG001', 'title': 'C-SES', 'description': 'Cordis Cypher® Sirolimus-eluting Coronary Stent\n\nStent : Stent implantation'}], 'classes': [{'title': 'Total death and large non-fatal myocardial infarct', 'categories': [{'measurements': [{'value': '225', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}]}, {'title': 'Total death and non-fatal myocardial infarctions', 'categories': [{'measurements': [{'value': '331', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}]}, {'title': 'Cardiac death and large non-fatal MI', 'categories': [{'measurements': [{'value': '157', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}]}, {'title': 'Cardiac death and non-fatal MI', 'categories': [{'measurements': [{'value': '265', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}]}]}, {'title': 'Target lesion revascularization', 'categories': [{'measurements': [{'value': '249', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}]}, {'title': 'Stroke', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}, {'title': 'Bleeding events', 'categories': [{'measurements': [{'value': '201', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'Total death and large non-fatal myocardial infarctions Total death and non-fatal myocardial infarctions Cardiac death and large non-fatal MI Cardiac death and non-fatal myocardial infarctions', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'E-ZES', 'description': 'Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System\n\nStent : Stent implantation'}, {'id': 'FG001', 'title': 'C-SES', 'description': 'Cordis Cypher® Sirolimus-eluting Coronary Stent\n\nStent : Stent implantation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4357'}, {'groupId': 'FG001', 'numSubjects': '4352'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4181'}, {'groupId': 'FG001', 'numSubjects': '4159'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '176'}, {'groupId': 'FG001', 'numSubjects': '193'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '176'}, {'groupId': 'FG001', 'numSubjects': '193'}]}]}], 'recruitmentDetails': '8709 patients were randomized from May 2007 until December 2008 in 196 participating hospitals in 36 countries across five continents.', 'preAssignmentDetails': '80 patients were excluded because there was no validly signed consent available during monitoring and 2 patients retracted their consent before the procedure, resulting in a total of 8709 patients randomised.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4357', 'groupId': 'BG000'}, {'value': '4352', 'groupId': 'BG001'}, {'value': '8709', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'E-ZES', 'description': 'Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System\n\nStent : Stent implantation'}, {'id': 'BG001', 'title': 'C-SES', 'description': 'Cordis Cypher® Sirolimus-eluting Coronary Stent\n\nStent : Stent implantation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2428', 'groupId': 'BG000'}, {'value': '2468', 'groupId': 'BG001'}, {'value': '4896', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1929', 'groupId': 'BG000'}, {'value': '1884', 'groupId': 'BG001'}, {'value': '3813', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.3', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '62.1', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '62.2', 'spread': '10.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1017', 'groupId': 'BG000'}, {'value': '1044', 'groupId': 'BG001'}, {'value': '2061', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3340', 'groupId': 'BG000'}, {'value': '3308', 'groupId': 'BG001'}, {'value': '6648', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Europe', 'categories': [{'measurements': [{'value': '3180', 'groupId': 'BG000'}, {'value': '3179', 'groupId': 'BG001'}, {'value': '6359', 'groupId': 'BG002'}]}]}, {'title': 'South Asia', 'categories': [{'measurements': [{'value': '623', 'groupId': 'BG000'}, {'value': '622', 'groupId': 'BG001'}, {'value': '1245', 'groupId': 'BG002'}]}]}, {'title': 'North America', 'categories': [{'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '230', 'groupId': 'BG002'}]}]}, {'title': 'South America', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '207', 'groupId': 'BG000'}, {'value': '207', 'groupId': 'BG001'}, {'value': '414', 'groupId': 'BG002'}]}]}, {'title': 'New Zealand', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}, {'title': 'Middle East', 'categories': [{'measurements': [{'value': '164', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '326', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Intention to treat analysis has been used.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8709}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-03', 'studyFirstSubmitDate': '2007-05-21', 'resultsFirstSubmitDate': '2013-09-17', 'studyFirstSubmitQcDate': '2007-05-21', 'lastUpdatePostDateStruct': {'date': '2014-11-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-02-03', 'studyFirstPostDateStruct': {'date': '2007-05-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Compare Overall Definite or Probable Stent Thrombosis Rate of the Endeavor® Zotarolimus Eluting Coronary Stent System Versus the Cypher® Sirolimus-eluting Coronary Stent in a Patient Population Requiring Stent Implantation', 'timeFrame': '3 years', 'description': 'Definite or probable stent thrombosis rate.'}], 'secondaryOutcomes': [{'measure': 'Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions', 'timeFrame': '3 years', 'description': 'Total death and large non-fatal myocardial infarctions Total death and non-fatal myocardial infarctions Cardiac death and large non-fatal MI Cardiac death and non-fatal myocardial infarctions'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Drug Eluting Stents', 'Interventional Cardiology'], 'conditions': ['Ischemic Heart Disease']}, 'referencesModule': {'references': [{'pmid': '19958855', 'type': 'BACKGROUND', 'citation': "Camenzind E, Wijns W, Mauri L, Boersma E, Parikh K, Kurowski V, Gao R, Bode C, Greenwood JP, Gershlick A, O'Neill W, Serruys PW, Jorissen B, Steg PG; PROTECT Steering Committee and Investigators. Rationale and design of the Patient Related OuTcomes with Endeavor versus Cypher stenting Trial (PROTECT): randomized controlled trial comparing the incidence of stent thrombosis and clinical events after sirolimus or zotarolimus drug-eluting stent implantation. Am Heart J. 2009 Dec;158(6):902-909.e5. doi: 10.1016/j.ahj.2009.10.002."}, {'pmid': '22951082', 'type': 'RESULT', 'citation': "Camenzind E, Wijns W, Mauri L, Kurowski V, Parikh K, Gao R, Bode C, Greenwood JP, Boersma E, Vranckx P, McFadden E, Serruys PW, O'Neil WW, Jorissen B, Van Leeuwen F, Steg PG; PROTECT Steering Committee and Investigators. Stent thrombosis and major clinical events at 3 years after zotarolimus-eluting or sirolimus-eluting coronary stent implantation: a randomised, multicentre, open-label, controlled trial. Lancet. 2012 Oct 20;380(9851):1396-405. doi: 10.1016/S0140-6736(12)61336-1. Epub 2012 Aug 27."}, {'pmid': '28335893', 'type': 'DERIVED', 'citation': 'Roguin A, Camenzind E, Kerner A, Beyar R, Boersma E, Mauri L, Steg PG, Wijns W. Long-Term Outcomes of Stenting the Proximal Left Anterior Descending Artery in the PROTECT Trial. JACC Cardiovasc Interv. 2017 Mar 27;10(6):548-556. doi: 10.1016/j.jcin.2016.12.028.'}, {'pmid': '25910523', 'type': 'DERIVED', 'citation': 'Secemsky EA, Matteau A, Yeh RW, Steg PG, Camenzind E, Wijns W, McFadden E, Mauri L; PROTECT Trial Investigators. Comparison of Short- and Long-Term Cardiac Mortality in Early Versus Late Stent Thrombosis (from Pooled PROTECT Trials). Am J Cardiol. 2015 Jun 15;115(12):1678-84. doi: 10.1016/j.amjcard.2015.03.010. Epub 2015 Mar 23.'}, {'pmid': '25106761', 'type': 'DERIVED', 'citation': 'Wijns W, Steg PG, Mauri L, Kurowski V, Parikh K, Gao R, Bode C, Greenwood JP, Lipsic E, Alamgir F, Rademaker-Havinga T, Boersma E, Radke P, van Leeuwen F, Camenzind E; PROTECT Steering Committee and Investigators. Endeavour zotarolimus-eluting stent reduces stent thrombosis and improves clinical outcomes compared with cypher sirolimus-eluting stent: 4-year results of the PROTECT randomized trial. Eur Heart J. 2014 Oct 21;35(40):2812-20. doi: 10.1093/eurheartj/ehu318. Epub 2014 Aug 8.'}, {'pmid': '24627416', 'type': 'DERIVED', 'citation': 'Camenzind E, Boersma E, Wijns W, Mauri L, Rademaker-Havinga T, Ordoubadi FF, Suttorp MJ, Al Kurdi M, Steg PG; PROTECT Steering Committee and Investigators. Modifying effect of dual antiplatelet therapy on incidence of stent thrombosis according to implanted drug-eluting stent type. Eur Heart J. 2014 Aug 1;35(29):1932-48. doi: 10.1093/eurheartj/ehu084. Epub 2014 Mar 13.'}]}, 'descriptionModule': {'briefSummary': 'The PROTECT TRIAL is a randomized stent trial with 8800 patients in approximately 200 hospitals, which is designed to evaluate whether the Endeavor stent PROTECTS against late stent thrombosis resulting in less deaths and myocardial infarctions.\n\nStudy Stents:\n\nMedtronic Endeavor® Zotarolimus Eluting Coronary Stent System or next generation model Cordis Cypher® Sirolimus-eluting Coronary Stent, Cordis Cypher Select® Sirolimus-eluting Coronary Stent or next generation model\n\nPrimary Objective: To compare overall stent thrombosis rate of the Endeavor® Zotarolimus Eluting Coronary Stent System versus the Cypher® Sirolimus-eluting Coronary Stent in a patient population requiring stent implantation\n\nSecondary Objective: To compare the composite endpoint of total death or cardiac death combined with the number of patients with all non-fatal myocardial infarctions as well as the number of patients with large non-fatal myocardial infarctions for Endeavor® Zotarolimus Eluting Coronary Stent System versus the Cypher® Sirolimus-eluting Coronary Stent in a patient population requiring stent implantation.\n\nTo assess the safety and efficacy in patient subgroups with specific demographics, clinical indications and/or vessel- or lesion characteristics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient is \\> 18 years of age (or minimum age as required by local regulations).\n2. The patient has consented to participate and has authorized the collection and release of his medical information by signing the "Patient Informed Consent Form".\n3. All lesions requiring interventions (target lesions - one to a maximum of four) in one or more native coronary arteries are amendable for implantation of one or more Endeavor® Zotarolimus Eluting Coronary Stent System or Cypher® Sirolimus-eluting Coronary Stent\\*.\n4. Patient indication, lesion length and vessel diameter of the target lesion(s) are according to the \'Indications for Use\' as mentioned in the \'Instructions for Use\' that comes with every Endeavor® Zotarolimus Eluting Coronary Stent System and Cypher® Sirolimus-eluting Coronary Stent. Patients should qualify for both systems before randomization\\*.\n5. The patient is willing and able to cooperate with study procedures and required follow up visits.\n\nExclusion Criteria:\n\n1. Women with known pregnancy or who are lactating.\n2. Planned elective surgery necessitating discontinuation of clopidogrel within the regular planned period of clopidogrel administration.\n3. Patients expected not to be compliant with the anti-platelet and/or anticoagulation therapy regimen.\n4. Previous brachy-therapy.\n5. Previous implantation of a drug eluting stent.\n6. Previous implantation of a bare metal stent in the preceding year.\n7. Simultaneous or planned intervention other non cardiac vessels including but not limited to renal artery or carotid artery.\n8. Current medical condition with a life expectancy of less than 3 years.\n9. Manifest acute severe heart failure (Killip class III-IV).\n10. The patient is currently, and during the first 3 years of the PROTECT trial, participating in another investigational device or drug study that clinically interferes with the PROTECT-study endpoints; or requires coronary angiography or other coronary artery imaging procedures. The patient may only be enrolled in the PROTECT-study once.\n11. Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this study.\n12. Patients on warfarin or similar anti-coagulant therapy.\n13. Patients with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use of either stents.\n14. Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon.\n15. Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated.\n16. Transplant patients.'}, 'identificationModule': {'nctId': 'NCT00476957', 'acronym': 'PROTECT', 'briefTitle': 'Randomized Study Comparing Endeavor With Cypher Stents (PROTECT)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Vascular'}, 'officialTitle': 'PROTECT Trial: Patient Related OuTcomes With Endeavor Versus Cypher Stenting Trial', 'orgStudyIdInfo': {'id': 'Version 1.0 - 12 April 2007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System', 'interventionNames': ['Device: Stent']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Cordis Cypher® Sirolimus-eluting Coronary Stent', 'interventionNames': ['Device: Stent']}], 'interventions': [{'name': 'Stent', 'type': 'DEVICE', 'otherNames': ['Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System'], 'description': 'Stent implantation', 'armGroupLabels': ['1']}, {'name': 'Stent', 'type': 'DEVICE', 'otherNames': ['Cordis Cypher® Sirolimus-eluting Coronary Stent'], 'description': 'Stent implantation', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maastricht', 'country': 'Netherlands', 'facility': '196 enrolling sites Worldwide', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Edoardo Camenzind, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Geneva, Switzerland'}, {'name': 'Laura Mauri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital, US"}, {'name': "William O'Neill, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami Miller School of Medicine, US'}, {'name': 'Prof. Patrick W. Serruys, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasmus Medical Center'}, {'name': 'Prof. Philippe Gabriel Steg, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Département de Cardiologie, Hôpital Bichat-Claude Bernard, Assistance Publique - Hôpitaux de Paris, France'}, {'name': 'William Wijns, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'O.L.V. Hospital, Aalst, Belgium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Vascular', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}