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

Primary Purpose

Ischemic Stroke

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Stent retriever endovascular device for thrombectomy

Intravenous thrombolysis by alteplase (Actilyse) (optional)

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Stroke, Cerebrovascular Accident, Brain ischemia, Intravenous thrombolysis, Stroke thrombectomy, Stent-retriever

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Patients with acute stroke after exclusion of intracranial haemorrhage on CT/MRI scan.
Confirmed diagnosis on CTA of persisting occlusion of the terminal Internal Carotid Artery (Car-T), proximal Middle Cerebral Artery (MCA, M1), proximal part of the insular segment of MCA (M2), proximal part of the anterior cerebral artery (A1), Basilar Artery (BA) or proximal part of the posterior cerebral artery (P1), consistent with the clinical symptoms. For inclusion in the study, CTA must not be performed later than 15 minutes after IVT start if given. For patients not treated with IVT, CTA should preferably be performed within 15 minutes of completion of the non-contrast CT but must be performed within 6 hours after stroke onset.
Eligible patients for IVT are treated according to clinical guidelines (Attachment 1), and IVT, if given, initiated within 4.5 h.
Initiation of thrombectomy is recommended within 6 hours after stroke onset but must be performed within to 8 hours if thrombectomy would still be of benefit for the patient as judged by the investigator.
Baseline NIHSS Score at initiation of IVT is recommended between 7 and 25 for anterior circulation stroke and ≥7 without upper limit for posterior circulation stroke (baseline NIHSS score should be assessed by an NIHSS-certified physician), but patients may also be included beyond these scores if thrombectomy would still be of benefit for the patient as judged by the investigator.
Age ≥18years.
Anticipated life expectancy of at least 6 months.
Patient or legal representative is competent to make a decision and has provided informed consent with regard to participation in the study, retrieval and storage of data and follow up procedures.
Initiation of endovascular procedure (DSA/TBY, defined as start with groin puncture) within 2 hours from the start of IVT, or after CTA if IVT is not given (for TBY arm patients).

Exclusion criteria:

Known significant pre-stroke disability (mRS ≥2).
Extended early ischemic changes for basilar artery occlusion, according to the judgment of treating physician based on routine clinical practice of the hospital; if technical possibility exists, early irreversible ischemic changes may be confirmed by pc-ASPECTS score < 8 on CTASI (2) or extensive DWI lesion on pre-treatment MRI.
Known pregnancy.
Participation in any other investigational drug or device study, currently or in the previous 30 days.

Sites / Locations

Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Thrombectomy

Control

Arm 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.

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.

Outcomes

Primary Outcome Measures

Categorical shift in modified Rankin Scale score at 3 months

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

Functional independence at 3 months 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

Proportion of patients with excellent outcome (mRS score 0-1) at 3 months

Length of in-hospital stay

Days to discharge from in-hospital ward to home/secondary care for survivors in thrombectomy vs. control

Home time stay

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

Recurrent stroke within 3 months

Recanalisation of the occluded artery for thrombectomy treated population

Recanalisation of the occluded artery for thrombectomy treated population, defined as at least TICI 2b flow in the treated territory after procedure

Time to revascularisation

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

Recanalisation of the occluded artery at 24h computerized tomography angiography /contrast-enhanced magnetic resonance angiography

Defined as AOL 2-3

Proportion of patients with recanalisation before thrombectomy

Defined as AOL 2-3

Reduction of infarct size

Reduction in infarct size (thrombectomy vs. control) at 22-36 hours

Neurological and functional improvement in relation to thrombus length

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)

All-cause mortality at 3 months

Neurological death within 7 days post treatment

Distal embolism/reocclusion demonstrated by follow-up computerized tomography angiography /contrast-enhanced magnetic resonance angiography

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)

Full Information

NCT ID

NCT02326428

First Posted

May 21, 2014

Last Updated

March 14, 2018

Sponsor

Karolinska Institutet

Collaborators

Swedish Heart Lung Foundation, Medtronic - MITG, Stryker Nordic, Phenox GmbH

1. Study Identification

Unique Protocol Identification Number

NCT02326428

Brief Title

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

Acronym

SITS Open

Official Title

An Open, Prospective, Blinded Evaluation, International, Multicentre, Controlled Study of Safety and Efficacy of Thrombectomy and Standard Stroke Care in Clinical Routine Treatment of Acute Occlusive Stroke Compared to Standard Stroke Care Only

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

January 2018 (Actual)

Study Completion Date

January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska Institutet

Collaborators

Swedish Heart Lung Foundation, Medtronic - MITG, Stryker Nordic, Phenox GmbH

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke

Keywords

Stroke, Cerebrovascular Accident, Brain ischemia, Intravenous thrombolysis, Stroke thrombectomy, Stent-retriever

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Non-Randomized

Enrollment

341 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Thrombectomy

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Stent retriever endovascular device for thrombectomy

Other Intervention Name(s)

Mechanical thrombectomy in ischemic stroke

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Intravenous thrombolysis by alteplase (Actilyse) (optional)

Other Intervention Name(s)

Stroke thrombolysis

Intervention Description

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)

Primary Outcome Measure Information:

Title

Categorical shift in modified Rankin Scale score at 3 months

Description

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.

Time Frame

90 (range 76-104) days from stroke onset

Secondary Outcome Measure Information:

Title

Functional independence at 3 months after stroke onset

Description

Proportion of patients with functional independence (modified Rankin Scale, mRS, score 0-2) at 3 months after stroke onset

Time Frame

90 (76-104) days after stroke onset

Title

Excellent recovery at 3 months

Description

Proportion of patients with excellent outcome (mRS score 0-1) at 3 months

Time Frame

90 (76-104) days after stroke onset

Title

Length of in-hospital stay

Description

Days to discharge from in-hospital ward to home/secondary care for survivors in thrombectomy vs. control

Time Frame

90 (76-104) days after stroke onset

Title

Home time stay

Description

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

Time Frame

90 (76-104) days after stroke onset

Title

Recurrent stroke within 3 months

Time Frame

90 (76-104) days after stroke onset

Title

Recanalisation of the occluded artery for thrombectomy treated population

Description

Recanalisation of the occluded artery for thrombectomy treated population, defined as at least TICI 2b flow in the treated territory after procedure

Time Frame

Title

Time to revascularisation

Description

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

Time Frame

Title

Recanalisation of the occluded artery at 24h computerized tomography angiography /contrast-enhanced magnetic resonance angiography

Description

Defined as AOL 2-3

Time Frame

22-36h

Title

Proportion of patients with recanalisation before thrombectomy

Description

Defined as AOL 2-3

Time Frame

Title

Reduction of infarct size

Description

Reduction in infarct size (thrombectomy vs. control) at 22-36 hours

Time Frame

22-36h

Title

Neurological and functional improvement in relation to thrombus length

Description

Time Frame

90 (76-104) days

Title

All-cause mortality at 3 months

Time Frame

90 (76-104) days

Title

Neurological death within 7 days post treatment

Time Frame

7 days

Title

Distal embolism/reocclusion demonstrated by follow-up computerized tomography angiography /contrast-enhanced magnetic resonance angiography

Description

Time Frame

22-36h

Title

Embolism into new territories (ENT)

Time Frame

22-36h

Other Pre-specified Outcome Measures:

Title

Symptomatic intracerebral haemorrhage (SICH) according to SITS-MOST definition

Description

• Symptomatic intracerebral haemorrhage (SICH) according to SITS-MOST definition: local or remote parenchymal haemorrhage type 2 on the 22- to 36-hour post-treatment imaging scan, combined with a neurological deterioration of ≥4 points compared with baseline NIHSS or the lowest NIHSS value or death between baseline and 24 hours.

Time Frame

22-36 h

Title

Symptomatic intracerebral haemorrhage (SICH) according to modified SITS-MOST definition

Description

• Symptomatic intracranial haemorrhage (SICH) according to modified SITS-MOST definition; in addition to usual SITS-MOST criteria blood may be anywhere in the intracranial space (including in the intraventricular, intraparenchymal and/or subarachnoid space).

Time Frame

22-36h

Title

Symptomatic intracerebral haemorrhage (SICH) according to modified ECASS III definition

Description

• Symptomatic intracranial haemorrhage (SICH) defined as an NIHSS decline of ≥4 points compared with baseline NIHSS or the lowest NIHSS value or death between baseline and 7 days, associated with any haemorrhage judged by core lab evaluation to be responsible for the decline. Blood may be anywhere in the intracranial space including in the intraventricular, intraparenchymal and/or subarachnoid space (modified ECASS III definition).

Time Frame

22-36h

Title

Number of adverse effects of thrombectomy

Description

Any adverse reactions related to thrombectomy procedure including patients for whom the initiating angiography revealed recanalisation by IVT only

Time Frame

up to 90 (76-104) days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Patients with acute stroke after exclusion of intracranial haemorrhage on CT/MRI scan. Confirmed diagnosis on CTA of persisting occlusion of the terminal Internal Carotid Artery (Car-T), proximal Middle Cerebral Artery (MCA, M1), proximal part of the insular segment of MCA (M2), proximal part of the anterior cerebral artery (A1), Basilar Artery (BA) or proximal part of the posterior cerebral artery (P1), consistent with the clinical symptoms. For inclusion in the study, CTA must not be performed later than 15 minutes after IVT start if given. For patients not treated with IVT, CTA should preferably be performed within 15 minutes of completion of the non-contrast CT but must be performed within 6 hours after stroke onset. Eligible patients for IVT are treated according to clinical guidelines (Attachment 1), and IVT, if given, initiated within 4.5 h. Initiation of thrombectomy is recommended within 6 hours after stroke onset but must be performed within to 8 hours if thrombectomy would still be of benefit for the patient as judged by the investigator. Baseline NIHSS Score at initiation of IVT is recommended between 7 and 25 for anterior circulation stroke and ≥7 without upper limit for posterior circulation stroke (baseline NIHSS score should be assessed by an NIHSS-certified physician), but patients may also be included beyond these scores if thrombectomy would still be of benefit for the patient as judged by the investigator. Age ≥18years. Anticipated life expectancy of at least 6 months. Patient or legal representative is competent to make a decision and has provided informed consent with regard to participation in the study, retrieval and storage of data and follow up procedures. Initiation of endovascular procedure (DSA/TBY, defined as start with groin puncture) within 2 hours from the start of IVT, or after CTA if IVT is not given (for TBY arm patients). Exclusion criteria: Known significant pre-stroke disability (mRS ≥2). Extended early ischemic changes for basilar artery occlusion, according to the judgment of treating physician based on routine clinical practice of the hospital; if technical possibility exists, early irreversible ischemic changes may be confirmed by pc-ASPECTS score < 8 on CTASI (2) or extensive DWI lesion on pre-treatment MRI. Known pregnancy. Participation in any other investigational drug or device study, currently or in the previous 30 days.

Overall Study Officials: