{
  "FullStudy":{
    "Rank":217698,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01517997",
          "OrgStudyIdInfo":{
            "OrgStudyId":"20884/25-8-11"
          },
          "Organization":{
            "OrgFullName":"University of Patras",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Infrapopliteal Drug Eluting Angioplasty Versus Stenting",
          "OfficialTitle":"Infrapopliteal Drug Eluting Angioplasty Versus Stenting for the Treatment of Long-segment Arterial Disease: The IDEAS-I Randomized Controlled Trial.",
          "Acronym":"IDEAS-I"
        },
        "StatusModule":{
          "StatusVerifiedDate":"October 2013",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"August 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"September 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"September 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"December 2, 2011",
          "StudyFirstSubmitQCDate":"January 20, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"October 8, 2013",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"October 9, 2013",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"SIABLIS DIMITRIOS",
            "ResponsiblePartyInvestigatorTitle":"Professor of RAdiology",
            "ResponsiblePartyInvestigatorAffiliation":"University of Patras"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University of Patras",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"In total 50 patients diagnosed with long-segment infrapopliteal arterial disease will be randomized in two groups. The patients randomized in the Drug coated balloons (DCB) study arm will undergo a percutaneous transluminal angioplasty (PTA) with the use of a paclitaxel-coated balloon, while the patients randomized in the drug-eluting stent (DES) study arm will undergo primary stenting using drug-eluting stent(s). The study's primary endpoints will be the 6-month angiographic binary restenosis rate. Secondary endpoints will include the immediate technical success,6-month primary patency, target lesion revascularization and limb salvage and complication rates.",
          "DetailedDescription":"Patients programmed to undergo PTA due to angiographically-proven infrapopliteal arterial disease in our department will be randomized in the above mentioned study arms. The studies primary endpoint will be assessed with the use of intra-arterial digital subtracted angiography and subsequent Quantitative Vascular Analysis (QVA) analysis.Clinical follow-up is set at 1, 3 and 6 months. Patients' baseline demographics and procedural details will be recorded and analyzed."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Arterial Occlusive Disease"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Drug coated balloons",
              "Drug eluting stents"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 2",
              "Phase 3"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Single",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"50",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Drug Coated Balloon (DCB) Arm",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Patients included in this arm will undergo PTA with the use of a paclitaxel coated balloon.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: Paclitaxel coated balloon angioplasty."
                  ]
                }
              },{
                "ArmGroupLabel":"Drug Eluting Stents (DES) Arm",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Patients in this arm will undergo primary infrapopliteal stenting of the target lesion using a drug-eluting stent.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: Infrapopliteal Primary Drug Eluting Stenting"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Procedure",
                "InterventionName":"Paclitaxel coated balloon angioplasty.",
                "InterventionDescription":"Infrapopliteal angioplasty using a paclitaxel coated balloon.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Drug Coated Balloon (DCB) Arm"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "DCB"
                  ]
                }
              },{
                "InterventionType":"Procedure",
                "InterventionName":"Infrapopliteal Primary Drug Eluting Stenting",
                "InterventionDescription":"Infrapopliteal primary stenting using drug-eluting stent(s)",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Drug Eluting Stents (DES) Arm"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "DES"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Angiographic Binary Restenosis",
                "PrimaryOutcomeDescription":"Angiographic binary restenosis of the target lesion defined by quantitative vessel analysis at 6 months follow-up",
                "PrimaryOutcomeTimeFrame":"6 months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Technical success rate",
                "SecondaryOutcomeDescription":"Successful balloon angioplasty without stent use due to flow limiting dissection or/and <30% remaining target lesion stenosis in the DCB arm and successful balloon angioplasty without flow limiting dissection or/and <30% remaining target lesion stenosis in the DES arm.",
                "SecondaryOutcomeTimeFrame":"intra-procedural"
              },{
                "SecondaryOutcomeMeasure":"Procedure related complication rates",
                "SecondaryOutcomeDescription":"procedure related major and minor complication rates identified during the procedure or within 30 days after the completion of the procedure.",
                "SecondaryOutcomeTimeFrame":"up to 30 days"
              },{
                "SecondaryOutcomeMeasure":"Target lesion revascularization",
                "SecondaryOutcomeDescription":"Clinically-driven target lesion re-intervention",
                "SecondaryOutcomeTimeFrame":"6 months"
              },{
                "SecondaryOutcomeMeasure":"Limb salvage",
                "SecondaryOutcomeDescription":"Major amputation-free interval of the treated limb at 6 months follow-up",
                "SecondaryOutcomeTimeFrame":"6 months"
              },{
                "SecondaryOutcomeMeasure":"Angiographic Primary Patency",
                "SecondaryOutcomeDescription":"Angiographically proven target lesion patency without any additional revascularization procedure",
                "SecondaryOutcomeTimeFrame":"6 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAngiographically documented infrapopliteal disease.\nRutherford category of peripheral arterial disease between class 3 to 6\nLesion length between 70 to 220 mm\nLesions situated in the proximal, mid and mid to distal segments of the tibial vessels.\n\nExclusion Criteria:\n\nLesion length < 70 mm or > 220 mm.\nLesions situated in the distal third of the tibial vessels",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"90 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Dimitrios Siablis, MD,PhD",
                "OverallOfficialAffiliation":"University Hospital of Patras",
                "OverallOfficialRole":"Study Chair"
              },{
                "OverallOfficialName":"Dimitrios Karnabatidis, MD, PhD",
                "OverallOfficialAffiliation":"University Hospital of Patras",
                "OverallOfficialRole":"Study Director"
              },{
                "OverallOfficialName":"Konstantinos Katsanos, MD, PhD",
                "OverallOfficialAffiliation":"University Hospital of Patras",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Stavros Spiliopoulos, MD, PhD",
                "OverallOfficialAffiliation":"University Hospital of Patras",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Athanasios Diamantopoulos, MD",
                "OverallOfficialAffiliation":"Patras Univesrity Hospital",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Panagiotis Kitrou, MD",
                "OverallOfficialAffiliation":"University Hospital of Patras",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Patras University Hospital",
                "LocationCity":"Rion",
                "LocationState":"Achaia",
                "LocationZip":"26500",
                "LocationCountry":"Greece"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"25234679",
                "ReferenceType":"derived",
                "ReferenceCitation":"Siablis D, Kitrou PM, Spiliopoulos S, Katsanos K, Karnabatidis D. Paclitaxel-coated balloon angioplasty versus drug-eluting stenting for the treatment of infrapopliteal long-segment arterial occlusive disease: the IDEAS randomized controlled trial. JACC Cardiovasc Interv. 2014 Sep;7(9):1048-56. doi: 10.1016/j.jcin.2014.04.015."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000017239",
                "InterventionMeshTerm":"Paclitaxel"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000000972",
                "InterventionAncestorTerm":"Antineoplastic Agents, Phytogenic"
              },{
                "InterventionAncestorId":"D000000970",
                "InterventionAncestorTerm":"Antineoplastic Agents"
              },{
                "InterventionAncestorId":"D000050257",
                "InterventionAncestorTerm":"Tubulin Modulators"
              },{
                "InterventionAncestorId":"D000050256",
                "InterventionAncestorTerm":"Antimitotic Agents"
              },{
                "InterventionAncestorId":"D000050258",
                "InterventionAncestorTerm":"Mitosis Modulators"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M18120",
                "InterventionBrowseLeafName":"Paclitaxel",
                "InterventionBrowseLeafAsFound":"Paclitaxel",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M231",
                "InterventionBrowseLeafName":"Albumin-Bound Paclitaxel",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M24784",
                "InterventionBrowseLeafName":"Tubulin Modulators",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M24783",
                "InterventionBrowseLeafName":"Antimitotic Agents",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"ANeo",
                "InterventionBrowseBranchName":"Antineoplastic Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000001157",
                "ConditionMeshTerm":"Arterial Occlusive Diseases"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000014652",
                "ConditionAncestorTerm":"Vascular Diseases"
              },{
                "ConditionAncestorId":"D000002318",
                "ConditionAncestorTerm":"Cardiovascular Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M3046",
                "ConditionBrowseLeafName":"Arterial Occlusive Diseases",
                "ConditionBrowseLeafAsFound":"Arterial Occlusive Disease",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M15983",
                "ConditionBrowseLeafName":"Vascular Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC14",
                "ConditionBrowseBranchName":"Heart and Blood Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}