{
  "FullStudy":{
    "Rank":218113,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01512563",
          "OrgStudyIdInfo":{
            "OrgStudyId":"MIRA-cover"
          },
          "Organization":{
            "OrgFullName":"Taewoong Medical Co., Ltd.",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Patency and Safety of the Drug Eluting Covered Biliary Stent Comparing to the Common Covered Biliary Stent",
          "OfficialTitle":"Clinical Trial Comparing Patency and Safety of the Paclitaxel Eluting Covered Metallic Biliary Stent(Niti-S Mira-Cover Biliary Stent ) to the Common Covered Metallic Biliary Stent(Niti-S Biliary Stent)",
          "Acronym":"MIRA-cover"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"February 2007"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"February 2010",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"February 2010",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 11, 2012",
          "StudyFirstSubmitQCDate":"January 15, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"March 9, 2020",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"March 11, 2020",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Taewoong Medical Co., Ltd.",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Paclitaxel covered metal biliary stent extents their patency rate comparing to the Common Covered Metallic Biliary Stent.",
          "DetailedDescription":"Paclitaxel covered metal biliary stent(Mira-Cover Biliary Stent) extents their patency rate comparing to the Common Covered Metallic Biliary Stent(Niti-S Biliary Stent."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Biliary Stricture",
              "Malignant Neoplasms"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "paclitaxel",
              "drug eluting stent"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Supportive Care",
            "DesignMaskingInfo":{
              "DesignMasking":"Single",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"106",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Paclitaxel ElutingCovered Metal Stent",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: Biliary stent"
                  ]
                }
              },{
                "ArmGroupLabel":"Covered Metal Stent",
                "ArmGroupType":"Active Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: Biliary stent"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Device",
                "InterventionName":"Biliary stent",
                "InterventionDescription":"palliative treatment for malignant patients",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Covered Metal Stent",
                    "Paclitaxel ElutingCovered Metal Stent"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Niti-S Mira-Cover Biliary Stent",
                    "Niti-S Biliary Stent"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Accumulative Patency Rate",
                "PrimaryOutcomeTimeFrame":"6 month"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Accumulative Survival Rate",
                "SecondaryOutcomeTimeFrame":"6 months"
              },{
                "SecondaryOutcomeMeasure":"Complications",
                "SecondaryOutcomeTimeFrame":"6 months"
              },{
                "SecondaryOutcomeMeasure":"Possibility of Other Treatment after Obstruction",
                "SecondaryOutcomeTimeFrame":"6 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nPatient who is inoperable and/or unresectable cases of pancreatic cancer and/or biliary cancer with mid or distal CBD invasion\nAmong patient of a.,Patient who previously had surgical biliary drainage of plastic stent have eligibility\n\nExclusion Criteria:\n\nPatient who have life expectancy under 3 months\nPatient who have severe metastasis of Liver or whole body\nPatient who previously had surgical biliary drainage",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"19 Years",
          "MaximumAge":"90 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Dong Ki Lee, Ph.D",
                "OverallOfficialAffiliation":"Kangnam Severance Hospital",
                "OverallOfficialRole":"Study Chair"
              },{
                "OverallOfficialName":"Ho Gak Kim",
                "OverallOfficialAffiliation":"Catholic University of Daegu School of Medicine",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Sang Heum Park",
                "OverallOfficialAffiliation":"Soon Chun Hyang University",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Soon Chun Hyang University Hospital Cheonan",
                "LocationCity":"Cheonan",
                "LocationCountry":"Korea, Republic of"
              },{
                "LocationFacility":"Catholic University of Daegu School of Medicine",
                "LocationCity":"Daegu",
                "LocationCountry":"Korea, Republic of"
              },{
                "LocationFacility":"Kangnam Severance Hospital",
                "LocationCity":"Seoul",
                "LocationZip":"135-720",
                "LocationCountry":"Korea, Republic of"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000003251",
                "ConditionMeshTerm":"Constriction, Pathologic"
              },{
                "ConditionMeshId":"D000009369",
                "ConditionMeshTerm":"Neoplasms"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000020763",
                "ConditionAncestorTerm":"Pathological Conditions, Anatomical"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M5058",
                "ConditionBrowseLeafName":"Constriction, Pathologic",
                "ConditionBrowseLeafAsFound":"Stricture",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M21103",
                "ConditionBrowseLeafName":"Pathological Conditions, Anatomical",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}