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

Not Applicable

Completed

• Conditions: Ischemic Stroke
• Interventions: Device: Stent retriever endovascular device for thrombectomy; Drug: Intravenous thrombolysis by alteplase (Actilyse) (optional)

• Registration Number: NCT02326428
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-12-22
• Study First Posted: 2014-12-29
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-14
• Last Update Posted: 2018-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 341

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thrombectomy	Intravenous thrombolysis by alteplase (Actilyse) (optional)	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.
Thrombectomy	Stent retriever endovascular device for thrombectomy	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.
Control	Intravenous thrombolysis by alteplase (Actilyse) (optional)	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.

Primary Outcome Measures

Name	Time	Method
Categorical shift in modified Rankin Scale score at 3 months	90 (range 76-104) days from stroke onset	Categorical shift towards better stroke outcome as reflected by lower, i.e. better, Rankin Scale scores over the range of the scale in active compared to control group.

Secondary Outcome Measures

Name	Time	Method
Length of in-hospital stay	90 (76-104) days after stroke onset	Days to discharge from in-hospital ward to home/secondary care for survivors in thrombectomy vs. control
Recanalisation of the occluded artery for thrombectomy treated population	6h	Recanalisation of the occluded artery for thrombectomy treated population, defined as at least TICI 2b flow in the treated territory after procedure
Recanalisation of the occluded artery at 24h computerized tomography angiography /contrast-enhanced magnetic resonance angiography	22-36h	Defined as AOL 2-3
Distal embolism/reocclusion demonstrated by follow-up computerized tomography angiography /contrast-enhanced magnetic resonance angiography	22-36h	Distal embolism/reocclusion will be evaluated by DSA immediately following the endovascular intervention and at the 22-36 hour follow up CT and CTA scans. The proportion of patients with recanalisation of the target occlusion and distal enbolism/reocclusion will be calculated.
Embolism into new territories (ENT)	22-36h
Functional independence at 3 months after stroke onset	90 (76-104) days after stroke onset	Proportion of patients with functional independence (modified Rankin Scale, mRS, score 0-2) at 3 months after stroke onset
Excellent recovery at 3 months	90 (76-104) days after stroke onset	Proportion of patients with excellent outcome (mRS score 0-1) at 3 months
Recurrent stroke within 3 months	90 (76-104) days after stroke onset
Time to revascularisation	6h	Time from stroke onset to revascularisation to any TICI (Thrombolysis in Cerebral Infarction) grade (2b-3 by core lab evaluation) for the actively treated population
Proportion of patients with recanalisation before thrombectomy	6h	Defined as AOL 2-3
Neurological and functional improvement in relation to thrombus length	90 (76-104) days	Neurological improvement (difference in National Institute of Health Stroke Scale from baseline to 12h, to 24h and to 7D after initiation of intravenous thrombolysis, or discharge if earlier), and functional outcome at 3 months in relation to recanalisation status and thrombus length (mm)
Neurological death within 7 days post treatment	7 days
All-cause mortality at 3 months	90 (76-104) days
Home time stay	90 (76-104) days after stroke onset	Number of days the patient stayed at home or at relative's stay within the first 3 months after stroke onset, in thrombectomy vs. control
Reduction of infarct size	22-36h	Reduction in infarct size (thrombectomy vs. control) at 22-36 hours

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden