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NCT Number: NCT02326428

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

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital

Stockholm, 17176, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stent retriever endovascular device for thrombectomy

Device

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

Other names: Mechanical thrombectomy in ischemic stroke

Intravenous thrombolysis by alteplase (Actilyse) (optional)

Drug

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)

Other names: Stroke thrombolysis

Primary outcomes

  1. Categorical shift in modified Rankin Scale score at 3 months

    Time frame: 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 outcomes

  1. Functional independence at 3 months after stroke onset

    Time frame: 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

  2. Excellent recovery at 3 months

    Time frame: 90 (76-104) days after stroke onset

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

  3. Length of in-hospital stay

    Time frame: 90 (76-104) days after stroke onset

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

  4. Home time stay

    Time frame: 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

  5. Recurrent stroke within 3 months

    Time frame: 90 (76-104) days after stroke onset

  6. Recanalisation of the occluded artery for thrombectomy treated population

    Time frame: 6h

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

  7. Time to revascularisation

    Time frame: 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

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

    Time frame: 22-36h

    Defined as AOL 2-3

  9. Proportion of patients with recanalisation before thrombectomy

    Time frame: 6h

    Defined as AOL 2-3

  10. Reduction of infarct size

    Time frame: 22-36h

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

  11. Neurological and functional improvement in relation to thrombus length

    Time frame: 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)

  12. All-cause mortality at 3 months

    Time frame: 90 (76-104) days

  13. Neurological death within 7 days post treatment

    Time frame: 7 days

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

    Time frame: 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.

  15. Embolism into new territories (ENT)

    Time frame: 22-36h

Other outcomes

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

    Time frame: 22-36 h

    • 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.

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

    Time frame: 22-36h

    • 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).

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

    Time frame: 22-36h

    • 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).

  4. Number of adverse effects of thrombectomy

    Time frame: up to 90 (76-104) days

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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

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

Registry information

Official study 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

Acronym: SITS Open

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Dec 29, 2014
Registry last updated
Mar 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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