Clinical trial NCT02326428: SITS (Safe Implementation of Treatments in Stroke) Open Artery by Thrombectomy in Acute Occlusive Stroke Study
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
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Keywords: Stroke
Cerebrovascular Accident
Brain ischemia
Intravenous thrombolysis
Stroke thrombectomy
Stent-retriever
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Swedish Heart Lung Foundation
name: Medtronic - MITG
name: Stryker Nordic
name: Phenox GmbH
First posted: 2014-12-29
Enrollment: 341
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Categorical shift in modified Rankin Scale score at 3 months
timeFrame: 90 (range 76-104) days from stroke onset
Secondary outcomes:
measure: Functional independence at 3 months after stroke onset
timeFrame: 90 (76-104) days after stroke onset
measure: Excellent recovery at 3 months
timeFrame: 90 (76-104) days after stroke onset
measure: Length of in-hospital stay
timeFrame: 90 (76-104) days after stroke onset
measure: Home time stay
timeFrame: 90 (76-104) days after stroke onset
measure: Recurrent stroke within 3 months
timeFrame: 90 (76-104) days after stroke onset
measure: Recanalisation of the occluded artery for thrombectomy treated population
timeFrame: 6h
measure: Time to revascularisation
timeFrame: 6h
measure: Recanalisation of the occluded artery at 24h computerized tomography angiography /contrast-enhanced magnetic resonance angiography
timeFrame: 22-36h
measure: Proportion of patients with recanalisation before thrombectomy
timeFrame: 6h
measure: Reduction of infarct size
timeFrame: 22-36h
measure: Neurological and functional improvement in relation to thrombus length
timeFrame: 90 (76-104) days
measure: All-cause mortality at 3 months
timeFrame: 90 (76-104) days
measure: Neurological death within 7 days post treatment
timeFrame: 7 days
measure: Distal embolism/reocclusion demonstrated by follow-up computerized tomography angiography /contrast-enhanced magnetic resonance angiography
timeFrame: 22-36h
measure: Embolism into new territories (ENT)
timeFrame: 22-36h
Other outcomes:
measure: Symptomatic intracerebral haemorrhage (SICH) according to SITS-MOST definition
timeFrame: 22-36 h
measure: Symptomatic intracerebral haemorrhage (SICH) according to modified SITS-MOST definition
timeFrame: 22-36h
measure: Symptomatic intracerebral haemorrhage (SICH) according to modified ECASS III definition
timeFrame: 22-36h
measure: Number of adverse effects of thrombectomy
timeFrame: up to 90 (76-104) days
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Nils Wahlgren, Professor
role: STUDY_CHAIR
affiliation: University Hospital of Schleswig-Holstein
name: Olav Jansen, Professor
role: STUDY_CHAIR
affiliation: Karolinska University Hospital, Karolinska Institutet
name: Staffan Holmin, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Glasgow
name: Kennedy Lees, M.D., FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Careggi University Hospital
name: Salvatore Mangiafico, M.D., Ph.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese University of Hong Kong
name: Lawrence Wong, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahmed N, Lees KR, von Kummer R, Holmin S, Escudero-Martinez I, Bottai M, Jansen O, Wahlgren N; Collaborators. The SITS Open Study: A Prospective, Open Label Blinded Evaluation Study of Thrombectomy in Clinical Practice. Stroke. 2021 Mar;52(3):792-801. doi: 10.1161/STROKEAHA.120.031031. Epub 2021 Feb 10.