None listed
Conditions
Brief summary
Thrombectomy for large vessel occlusion (LVO) has been the mainstay since publications of 5 landmark trials in 2015. However, these trials had very restrictive inclusion criteria and excluded elderly patients or those with premorbid disability. The aim of this trial is to deliver high quality evidence of the effectiveness of LVO thrombectomy in patients with premorbid disability.
Interventions
Patients randomized to the thrombectomy arm will have clot extraction or aspiration catheter in the angiographic suite. This procedure may be performed under general anaesthesia. This decision is up to the interventional radiologists performing the procedure. The procedure may take 1 hour but can be longer for complex anatomy or clot. Following the procedure the interventional neuroradiologists will document the procedure in electronic medical record. Post-intervention: A non-contrast Computed T
Patients randomized to the thrombectomy arm will have clot extraction or aspiration catheter in the angiographic suite. This procedure may be performed under general anaesthesia. This decision is up to the interventional radiologists performing the procedure. The procedure may take 1 hour but can be longer for complex anatomy or clot. Following the procedure the interventional neuroradiologists will document the procedure in electronic medical record. Post-intervention: A non-contrast Computed Tomography (CT) and CT Angiography will be performed 24-to-48-hour post intervention. At the investigator’s discretion, a repeat CT Perfusion or Magnetic Resonance IMaging (MRI) may be performed at 24-to-48 hr.
Sponsors
National Health and Medical Research Council
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients presenting with acute ischaemic stroke within 24 hours of stroke onset (in line with current criteria for thrombolysis). 2. National Institute of Health Stroke Scale (NIHSS)>4 3. Pre-stroke modified Rankin Score (mRS) score of 3 or 4 4. Patient’s age is 18 years and over (or as per local requirements) 5. Endovascular therapy (arterial puncture) within 90 minutes of initial CT brain. 6. Arterial occlusion on CT Angiography or MR Angiography (MRA) of large vessel occlusion (LVO)
Exclusion criteria
1. Patients presenting with acute ischaemic stroke >24 hours of stroke onset. 2. Intracranial haemorrhage identified by CT or MRI. 3. Rapidly improving symptoms at the discretion of the investigator 4. Pre-stroke modified Rankin Score (mRS) score of <3 (indicating previous disability) 5. Hypodensity in >1/2 MCA or ACA territory on non-contrast CT. 6. Contraindication to imaging with contrast agents (requirement for performing thrombectomy) 7. Any terminal illness such that the patient has life expectance less than 1 year. 8. Patients with active cancer and undergoing treatment for cancer are excluded. 9. Any condition that, in the judgment of the investigator, could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study. 10. Pregnancy
Outcome results
None listed