{
  "FullStudy":{
    "Rank":218246,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01510821",
          "OrgStudyIdInfo":{
            "OrgStudyId":"IRB00049331"
          },
          "Organization":{
            "OrgFullName":"Emory University",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Investigation of Endothelium in Saphenous Vein Grafts",
          "OfficialTitle":"A Prospective Trial to Investigate Endothelial Dysfunction in Saphenous Vein Grafts Subjected to the Maquet Vasoshield Pressure Limiting Syringe Versus Non-Regulated Vessel Dilation in Patients Undergoing Coronary Artery Bypass Grafting"
        },
        "StatusModule":{
          "StatusVerifiedDate":"September 2013",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"November 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"June 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"June 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"November 2, 2011",
          "StudyFirstSubmitQCDate":"January 14, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 18, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"September 30, 2013",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"October 1, 2013",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Vinod Thourani",
            "ResponsiblePartyInvestigatorTitle":"Associate Professor of Surgery",
            "ResponsiblePartyInvestigatorAffiliation":"Emory University"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Emory University",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Maquet Cardiovascular",
                "CollaboratorClass":"INDUSTRY"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"This is a single center prospective study of 30 patients undergoing elective heart bypass surgery (CABG) with at least two vein grafts from the leg (SVG). The purpose of this ex vivo study is to evaluate the function of vein grafts from small tissue samples treated with a pressure syringe and a non-pressure syringe. Syringes are routinely used to flush out the veins in preparation of bypass grafting. It is unknown if different levels of pressure in the syringe affect the vein or damage the vein. Small sections of tissue samples which are normally discarded will be obtained immediately after retrieval from the leg and before grafting to the heart. Tissue samples will be taken to the laboratory for study. There are no clinical endpoints in this study, however, clinical information will be obtained from the Society of Thoracic Surgeons database and will include demographics, risk factors, and perioperative outcomes."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Endothelial Function of Saphenous Vein Grafts"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "endoscopic vein harvest",
              "saphenous vein graft",
              "endothelial function"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Basic Science",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"30",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Maquet Vasoshield Arm",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Pressure limiting syringe",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Use of Maquet Vasoshield Pressure-limiting syringe on SVG"
                  ]
                }
              },{
                "ArmGroupLabel":"Non-regulated Arm",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"standard non-regulated syringe",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Use of non-regulated syringe on SVG"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Other",
                "InterventionName":"Use of Maquet Vasoshield Pressure-limiting syringe on SVG",
                "InterventionDescription":"Use of Maquet Vasoshield Pressure-limiting syringe on SVG",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Maquet Vasoshield Arm"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Maquet device"
                  ]
                }
              },{
                "InterventionType":"Other",
                "InterventionName":"Use of non-regulated syringe on SVG",
                "InterventionDescription":"Use of non-regulated syringe on SVG",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Non-regulated Arm"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "standard syringe"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"SVG vascular contractility",
                "PrimaryOutcomeTimeFrame":"Day of surgery"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Nitric oxide metabolite levels",
                "SecondaryOutcomeTimeFrame":"Day of surgery"
              },{
                "SecondaryOutcomeMeasure":"Major adverse cardiac events",
                "SecondaryOutcomeTimeFrame":"6 months and 1 year"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\npatients undergoing elective coronary artery bypass graft surgery requiring at least 2 saphenous vein grafts\n\nExclusion Criteria:\n\npatients undergoing any concomitant surgical procedures",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"21 Years",
          "MaximumAge":"90 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Vinod Thourani, MD",
                "OverallOfficialAffiliation":"Emory University",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Cardiothoracic Surgery Research Laboratory",
                "LocationCity":"Atlanta",
                "LocationState":"Georgia",
                "LocationZip":"30308",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"Emory University Hospital Midtown",
                "LocationCity":"Atlanta",
                "LocationState":"Georgia",
                "LocationZip":"30308",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M5875",
                "ConditionBrowseLeafName":"Dilatation, Pathologic",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}