{
  "FullStudy":{
    "Rank":218270,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01510509",
          "OrgStudyIdInfo":{
            "OrgStudyId":"TITANIC-XV"
          },
          "Organization":{
            "OrgFullName":"Hospital Universitario Infanta Cristina",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"The Titan Versus Everolimus Intracoronary Stent (Xience V) in Diabetic Patients",
          "OfficialTitle":"TITANIC-XV Trial: Prospective, Multicenter and Randomized Trial (Bioactive Bare Metal Titanium Stent Versus Everolimus Drug Eluting Stent)",
          "Acronym":"TITANIC-XV"
        },
        "StatusModule":{
          "StatusVerifiedDate":"December 2008",
          "OverallStatus":"Unknown status",
          "LastKnownStatus":"Active, not recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2009"
          },
          "StudyFirstSubmitDate":"January 11, 2012",
          "StudyFirstSubmitQCDate":"January 13, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 16, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 13, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 16, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Jose Ramon Lopez Minguez",
            "ResponsiblePartyInvestigatorTitle":"MD, PhD, Chief of Interventional Cardiology Deparment",
            "ResponsiblePartyInvestigatorAffiliation":"Hospital Universitario Infanta Cristina"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Hospital Universitario Infanta Cristina",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"Even though the safety of drug eluting stents has been long established, in roughly 25% o patients their implantation is not considered, for specifically clinical reasons (chronic anticoagulation, bleeding, etc…), which make prolonged use of clopidogrel unsuitable. A considerable percentage of these patients have diabetes mellitus, a well known risk factor for stent thrombosis. Recently, the special characteristics of the titanium stent with nitric oxide have been described, causing it to be considered as a bioactive stent.\n\nThe TITANIC-XV trial was a prospective randomized multi-center active-treatment-controlled clinical trial, with the chief aim to evaluate clinical outcome after titanium bare metal stent (Titan2®, Hexacath, Paris, France) implantation as compared with everolimus drug eluting stent (Xience-V®, Abbott Vascular, Santa Clara, California, USA) in diabetic patients undergoing percutaneous coronary intervention."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Diabetes Mellitus",
              "Percutaneous Coronary Intervention"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Drug Eluting Stent",
              "Bioactive Bare Metal Stent"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 4"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Titanium bare metal stent",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Titanium bare metal stent (Titan2®, Hexacath, Paris, France)",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: Titanium bare metal stent (Titan2®)"
                  ]
                }
              },{
                "ArmGroupLabel":"Everolimus Drug Eluting Stent",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Xience-V®, Abbott Vascular, Santa Clara, California, USA",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: Everolimus Drug Eluting Stent (Xience-V®)"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Device",
                "InterventionName":"Titanium bare metal stent (Titan2®)",
                "InterventionDescription":"Titan2®, Hexacath, Paris, France",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Titanium bare metal stent"
                  ]
                }
              },{
                "InterventionType":"Device",
                "InterventionName":"Everolimus Drug Eluting Stent (Xience-V®)",
                "InterventionDescription":"Xience-V®, Abbott Vascular, Santa Clara, California, USA",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Everolimus Drug Eluting Stent"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Major adverse cardiac events",
                "PrimaryOutcomeDescription":"Comparison of major adverse cardiac events defined as death, non fatal myocardial infarction, brain stroke or new revascularization at 1, 6, 12 and 24 months follow-up between the two treatment strategies."
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Late luminal loss",
                "SecondaryOutcomeDescription":"Comparison of late luminal loss within the in-segment zone at 9 months between the two treatment strategies in the subgroup of patients with angiographic follow-up."
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAge over 18 years\nDiabetes mellitus according to the World Health Organization Report\nPercutaneous coronary intervention due to at least one significant de novo lesion (defined as at least 50% diameter stenosis by visual estimation) in a native coronary artery or coronary bypass graft.\nInformed Consent \"signed\"\n\nExclusion Criteria:\n\nInclusion in another clinical research protocol\nPregnancy\nSTEMI within 48 hours\nUnprotected left main disease\nRestenotic lesions\nStent diameter < 2,5 mm or > 3,5 mm\nStent length more than 28 mm in < 3 mm vessels\nChronic total occlusions\nAllergy to aspirin, clopidogrel, heparin or abciximab\nActive bleeding or a significant increase in bleeding risk\nSignificant renal insufficiency defined as creatinine > 2 mg/dl\nSeverely depressed LV function (EF≤35%)\nCardiogenic shock\nIschemic stroke within the last 6 months\nContraindication for DES\nDisease with life expectancy < 12 months",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"85 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Jose Ramon Lopez-Minguez, MD",
                "OverallOfficialAffiliation":"Hospital Universitario Infanta Cristina (Badajoz, Spain). Interventional Cardiology Department.",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Heart Center, Satakunta Hospital, Pori, Finland",
                "LocationCity":"Satakunta",
                "LocationState":"Pori",
                "LocationZip":"28500",
                "LocationCountry":"Finland"
              },{
                "LocationFacility":"Hospital de Torrevieja",
                "LocationCity":"Torrevieja",
                "LocationState":"Alicante",
                "LocationZip":"03180",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital Puerto Real de Cádiz",
                "LocationCity":"Puerto Real",
                "LocationState":"Cadiz",
                "LocationZip":"11510",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital Universitario Puerta de Hierro Majadahonda",
                "LocationCity":"Majadahonda",
                "LocationState":"Madrid",
                "LocationZip":"28222",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital Universitario Infanta Cristina",
                "LocationCity":"Badajoz",
                "LocationZip":"06006",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital Juan Ramón Jiménez de Huelva",
                "LocationCity":"Huelva",
                "LocationZip":"21005",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital Virgen de la Salud de Toledo",
                "LocationCity":"Toledo",
                "LocationZip":"45004",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital General Universitario de Valencia",
                "LocationCity":"Valencia",
                "LocationZip":"46014",
                "LocationCountry":"Spain"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000068338",
                "InterventionMeshTerm":"Everolimus"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000000970",
                "InterventionAncestorTerm":"Antineoplastic Agents"
              },{
                "InterventionAncestorId":"D000007166",
                "InterventionAncestorTerm":"Immunosuppressive Agents"
              },{
                "InterventionAncestorId":"D000007155",
                "InterventionAncestorTerm":"Immunologic Factors"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M255",
                "InterventionBrowseLeafName":"Everolimus",
                "InterventionBrowseLeafAsFound":"Everolimus",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M8795",
                "InterventionBrowseLeafName":"Immunosuppressive Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M8784",
                "InterventionBrowseLeafName":"Immunologic Factors",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"ANeo",
                "InterventionBrowseBranchName":"Antineoplastic Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M5698",
                "ConditionBrowseLeafName":"Diabetes Mellitus",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC18",
                "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC19",
                "ConditionBrowseBranchName":"Gland and Hormone Related Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}