{
  "FullStudy":{
    "Rank":217929,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01514994",
          "OrgStudyIdInfo":{
            "OrgStudyId":"ST-1486"
          },
          "Organization":{
            "OrgFullName":"Spectranetics Corporation",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Valvuloplasty Scoring Balloon Catheter First-in-Man Study",
          "OfficialTitle":"Treatment of Critical Aortic Valve Stenosis Using a Novel Valvuloplasty Scoring Balloon Catheter: a First-in-Man Study"
        },
        "StatusModule":{
          "StatusVerifiedDate":"April 2016",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"June 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2014",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"September 2015",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 11, 2012",
          "StudyFirstSubmitQCDate":"January 18, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 23, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"April 15, 2016",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"April 18, 2016",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Spectranetics Corporation",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The Valvuloplasty Scoring Balloon First-in-Man study is a prospective, single arm, two phase, observational registry to demonstrate the safety and efficacy of the Valvuloplasty Scoring Balloon Catheter for the treatment of critical aortic valve stenosis.",
          "DetailedDescription":"Phase 1 will enroll patient who are scheduled to undergo open surgical aortic valve replacement and will have the Valvuloplasty Scoring Balloon delivered to their stenotic aortic valve through a standard aortotomy and deployed immediately prior to valve replacement.\n\nPhase 2 will enroll patients with aortic valve stenosis who are deemed to not be suitable candidates for elective surgical aortic valve replacement and in whom the investigational Valvuloplasty Scoring Balloon will be used as a stand-alone Valvuloplasty procedure or \"bridge\" to trans-catheter aortic valve implantation (TAVI) or surgery."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Aortic Valve Stenosis"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"25",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"AngioScore's Valvuloplasty Scoring Balloon",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: AngioScore's Valvuloplasty Scoring Balloon"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Device",
                "InterventionName":"AngioScore's Valvuloplasty Scoring Balloon",
                "InterventionDescription":"All patients will receive treatment for their aortic valve stenosis with the Valvuloplasty Scoring Balloon Catheter.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "AngioScore's Valvuloplasty Scoring Balloon"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Procedural Success",
                "PrimaryOutcomeDescription":"Procedural success defined as a >50% increase in the aortic valve effective orifice area and less than or equal to 2+ valvular regurgitation at the end of the percutaneous valvuloplasty procedure utilizing echocardiography, hemodynamic measurements and angiography.",
                "PrimaryOutcomeTimeFrame":"1 day"
              },{
                "PrimaryOutcomeMeasure":"Number of participants who do not experience death, stroke, myocardial infarction or emergency cardiac surgery during their hospitalization.",
                "PrimaryOutcomeDescription":"Freedom from in-hospital death, stroke, myocardial infarction or emergency cardiac surgery",
                "PrimaryOutcomeTimeFrame":"Participants will be followed for the duration of the hospital stay, an expected average of 48 hours"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nNative, degenerative-calcific, tricuspid, aortic valve stenosis with echocardiographic derived criteria: mean gradient of >40 mm Hg or Doppler peak systolic velocity greater than 4.0 m/s or an initial aortic valve area < 0.8 cm2.\nSymptomatic aortic valve disease as demonstrated by CCS Functional Class II or greater\nAortic valve annulus of greater than or equal to 18 mm and less than or equal to 28 mm measured on pre-procedure TTE.\nPhase 1 patients must be scheduled for a surgical aortic valve replacement.\nPhase 2 patients must not be suitable candidates for elective surgical aortic valve replacement.\n\nExclusion Criteria:\n\nRecent myocardial infarction (<30days)\nUnicuspid or bicuspid aortic valve or non-calcific aortic valve stenosis\nAny sepsis, including active endocarditis\nConcomitant 2+ or greater aortic valve valve regurgitation\nLVEF < 20%\nCVA or TIA within the previous 6 months\nPrevious aortic valve replacement (bioprosthetic or mechanical)",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"John G. Webb, MD",
                "OverallOfficialAffiliation":"St. Paul's Hospital, Vancouver, Canada",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"St. Paul's Hospital",
                "LocationCity":"Vancouver",
                "LocationState":"British Columbia",
                "LocationZip":"V6Z1Y6",
                "LocationCountry":"Canada"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000001024",
                "ConditionMeshTerm":"Aortic Valve Stenosis"
              },{
                "ConditionMeshId":"D000003251",
                "ConditionMeshTerm":"Constriction, Pathologic"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000020763",
                "ConditionAncestorTerm":"Pathological Conditions, Anatomical"
              },{
                "ConditionAncestorId":"D000006349",
                "ConditionAncestorTerm":"Heart Valve Diseases"
              },{
                "ConditionAncestorId":"D000006331",
                "ConditionAncestorTerm":"Heart Diseases"
              },{
                "ConditionAncestorId":"D000002318",
                "ConditionAncestorTerm":"Cardiovascular Diseases"
              },{
                "ConditionAncestorId":"D000014694",
                "ConditionAncestorTerm":"Ventricular Outflow Obstruction"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M5058",
                "ConditionBrowseLeafName":"Constriction, Pathologic",
                "ConditionBrowseLeafAsFound":"Stenosis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M2921",
                "ConditionBrowseLeafName":"Aortic Valve Stenosis",
                "ConditionBrowseLeafAsFound":"Aortic Valve Stenosis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M21103",
                "ConditionBrowseLeafName":"Pathological Conditions, Anatomical",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8020",
                "ConditionBrowseLeafName":"Heart Valve Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8002",
                "ConditionBrowseLeafName":"Heart Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M16023",
                "ConditionBrowseLeafName":"Ventricular Outflow Obstruction",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T450",
                "ConditionBrowseLeafName":"Aortic Valve Stenosis",
                "ConditionBrowseLeafAsFound":"Aortic Valve Stenosis",
                "ConditionBrowseLeafRelevance":"high"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC14",
                "ConditionBrowseBranchName":"Heart and Blood Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"Rare",
                "ConditionBrowseBranchName":"Rare Diseases"
              }
            ]
          }
        }
      }
    }
  }
}