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

NCT02326428 | Completed DMC

• 1 other identifier: SITS Open
• Study Type: interventional
• Target: 341
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Functional independence at 3 months after stroke onset

  90 (76-104) days after stroke onset

• Excellent recovery at 3 months

  90 (76-104) days after stroke onset

• Length of in-hospital stay

  90 (76-104) days after stroke onset

• Home time stay

  90 (76-104) days after stroke onset

• Recurrent stroke within 3 months

  90 (76-104) days after stroke onset

Other Outcomes (4)

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

  22-36 h

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

  22-36h

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

  22-36h

Study Arms (2)

Thrombectomy

EXPERIMENTAL

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.

Device: Stent retriever endovascular device for thrombectomy; Drug: Intravenous thrombolysis by alteplase (Actilyse) (optional)

Control

ACTIVE COMPARATOR

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.

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

Interventions

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

Also known as: Mechanical thrombectomy in ischemic stroke

Thrombectomy

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)

Also known as: Stroke thrombolysis

Control; Thrombectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Swedish Heart Lung Foundation: collaborator
• Medtronic - MITG: collaborator
• Stryker Nordic: collaborator
• Phenox GmbH: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Related Publications (1)

• 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.

  PMID: 33563015 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Brain Ischemia

Interventions

Thrombectomy; Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Officials

• Nils Wahlgren, Professor

  Karolinska Institutet

  STUDY CHAIR

• Olav Jansen, Professor

  University Hospital of Schleswig-Holstein

  STUDY CHAIR

• Staffan Holmin, M.D., Ph.D.

  Karolinska University Hospital, Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Kennedy Lees, M.D., FRCP

  University of Glasgow

  PRINCIPAL INVESTIGATOR

• Salvatore Mangiafico, M.D., Ph.

  Careggi University Hospital

  PRINCIPAL INVESTIGATOR

• Lawrence Wong, M.D., Ph.D.

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: December 29, 2014
• Study Start: March 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: March 15, 2018

Record last verified: 2018-03

Locations

SE (1)