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

Ischemic Stroke Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02326428
• Other study ID #: SITS Open
• Status: Completed
• Phase: N/A
• First received: May 21, 2014
• Last updated: March 14, 2018
• Start date: March 2014
• Est. completion date: January 2018

Study information

• Verified date: March 2018
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 341
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Device:
• Stent retriever endovascular device for thrombectomy
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

Drug:
• Intravenous thrombolysis by alteplase (Actilyse) (optional)
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)

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (5)

Lead Sponsor	Collaborator
Karolinska Institutet	Medtronic - MITG, Phenox GmbH, Stryker Nordic, Swedish Heart Lung Foundation

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Symptomatic intracerebral haemorrhage (SICH) according to SITS-MOST definition	• 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.	22-36 h
Other	Symptomatic intracerebral haemorrhage (SICH) according to modified SITS-MOST definition	• 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).	22-36h
Other	Symptomatic intracerebral haemorrhage (SICH) according to modified ECASS III definition	• 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).	22-36h
Other	Number of adverse effects of thrombectomy	Any adverse reactions related to thrombectomy procedure including patients for whom the initiating angiography revealed recanalisation by IVT only	up to 90 (76-104) days
Primary	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.	90 (range 76-104) days from stroke onset
Secondary	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	90 (76-104) days after stroke onset
Secondary	Excellent recovery at 3 months	Proportion of patients with excellent outcome (mRS score 0-1) at 3 months	90 (76-104) days after stroke onset
Secondary	Length of in-hospital stay	Days to discharge from in-hospital ward to home/secondary care for survivors in thrombectomy vs. control	90 (76-104) days after stroke onset
Secondary	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	90 (76-104) days after stroke onset
Secondary	Recurrent stroke within 3 months		90 (76-104) days after stroke onset
Secondary	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	6h
Secondary	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	6h
Secondary	Recanalisation of the occluded artery at 24h computerized tomography angiography /contrast-enhanced magnetic resonance angiography	Defined as AOL 2-3	22-36h
Secondary	Proportion of patients with recanalisation before thrombectomy	Defined as AOL 2-3	6h
Secondary	Reduction of infarct size	Reduction in infarct size (thrombectomy vs. control) at 22-36 hours	22-36h
Secondary	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)	90 (76-104) days
Secondary	All-cause mortality at 3 months		90 (76-104) days
Secondary	Neurological death within 7 days post treatment		7 days
Secondary	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.	22-36h
Secondary	Embolism into new territories (ENT)		22-36h