SITS (Safe Implementation of Treatments in Stroke) Open Artery by Thrombectomy in Acute Occlusive Stroke Study "SITS Open"

Completed

Phase N/A Results N/A

Trial Description

Ischemic stroke, i.e. irreversible damage of a part of the patient's brain, is caused by the formation of blood clot in the major vessel which gives blood supply to a certain part of the brain. At early time, within the first 4,5 hours, the conventional treatment is to try to dissolve this blood clot with a medication ("thrombolytic drug") which is administered to the blood through the needle in the vein. If the clot still remains there, additional treatment is possible - going directly to the clot via artery and taking it out with a special device. Patients may be included even if they are not treated with intravenous thrombolysis because of contraindication or other reasons. The purpose of the present study is to evaluate the benefit and safety efficacy of thrombectomy and standard stroke care in clinical routine treatment of acute occlusive stroke compared to standard stroke care only.

Conditions

Interventions

  • Stent retriever endovascular device for thrombectomy Device
    Other Names: Mechanical thrombectomy in ischemic stroke
    Intervention Desc: Thrombectomy by selected stent retrievers (TREVO, Solitaire, pREset, in special cases all stent retrievers) as additional therapy in major artery occlusion in patients fulfilling criteria for and receiving intravenous thrombolysis
    ARM 1: Kind: Experimental
    Label: Thrombectomy after IV thrombolysis
    Description: Stent retriever endovascular device for thrombectomy. Stroke patients who meet accepted criteria for intravenous thrombolysis, with initiation of treatment within 4.5 h, and further treated at a certified study centre with mechanical thrombectomy with stent-retriever
    ARM 2: Kind: Experimental
    Label: Thrombectomy
    Description: Thrombectomy arm consists of patients undergoing thrombectomy according to accepted critera in the judgement of investigator. Patients may be included even if they are not treated with intravenous thrombolysis because of contraindication or other reasons.
  • Intravenous thrombolysis by alteplase (Actilyse) Drug
    Other Names: Stroke thrombolysis
    Intervention Desc: Stroke thrombolysis with Alteplase (Boeringer-Ingelheim, ATC-code B01AD02; a fibrinolytic drug) according to conventional guidelines (0.9 mg/kg, not exceeding 90 mg, given intravenously)
    ARM 1: Kind: Experimental
    Label: Thrombectomy after IV thrombolysis
    Description: Stent retriever endovascular device for thrombectomy. Stroke patients who meet accepted criteria for intravenous thrombolysis, with initiation of treatment within 4.5 h, and further treated at a certified study centre with mechanical thrombectomy with stent-retriever
    ARM 2: Kind: Experimental
    Label: Conventional IV thrombolysis
    Description: Intravenous thrombolysis by alteplase. Control stroke patients who were treated with intravenous thrombolysis in study centres that do not practice thrombectomy
  • Intravenous thrombolysis by alteplase (Actilyse) (optional) Drug
    Other Names: Stroke thrombolysis
    Intervention Desc: Stroke thrombolysis with Alteplase (Boeringer-Ingelheim, ATC-code B01AD02; a fibrinolytic drug) according to conventional guidelines (0.9 mg/kg, not exceeding 90 mg, given intravenously)
    ARM 1: Kind: Experimental
    Label: Thrombectomy
    Description: Thrombectomy arm consists of patients undergoing thrombectomy according to accepted critera in the judgement of investigator. Patients may be included even if they are not treated with intravenous thrombolysis because of contraindication or other reasons.
    ARM 2: Kind: Experimental
    Label: Control
    Description: Control arm patients are treated with standard stroke care including IVT but do not receive Thrombectomy. Control arm consists of patients fulfilling criteria for thrombectomy according to accepted critera in the judgement of investigator. Patients may be included even if they are not treated with intravenous thrombolysis because of contraindication or other reason.

Trial Design

  • Allocation: Non-Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Categorical shift in modified Rankin Scale score at 3 months 90 (range 76-104) days from stroke onset No
Secondary Functional independence at 3 months after stroke onset 90 (76-104) days after stroke onset No
Secondary Excellent recovery at 3 months 90 (76-104) days after stroke onset No
Secondary Length of in-hospital stay 90 (76-104) days after stroke onset No
Secondary Home time stay 90 (76-104) days after stroke onset No
Secondary Recurrent stroke during follow up 90 (76-104) days after stroke onset No
Secondary Recanalisation of the occluded artery for actively treated population 6h No
Secondary Time to revascularisation 6h No
Secondary Recanalisation of the occluded artery at 24h computerized tomography angiography /contrast-enhanced magnetic resonance angiography 22-36h No
Secondary Proportion of patients with recanalisation before thrombectomy in the active arm 6h No
Secondary Reduction of infarct size 22-36h No
Secondary Neurological and functional improvement in relation to thrombus length 90 (76-104) days No
Secondary All-cause mortality at 3 months 90 (76-104) days Yes
Secondary Neurological death within 7 days post treatment 7 days Yes
Secondary Distal embolism/reocclusion demonstrated by follow-up computerized tomography angiography /contrast-enhanced magnetic resonance angiography 22-36h Yes
Secondary Recurrent stroke within 3 months 90 (76-104) days after stroke onset
Secondary Recanalisation of the occluded artery for thrombectomy treated population 6h
Secondary Proportion of patients with recanalisation before thrombectomy 6h
Secondary Embolism into new territories (ENT) 22-36h

Sponsors