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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 341
- Locations
- 1
- Primary Endpoint
- Categorical shift in modified Rankin Scale score at 3 months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Thrombectomy
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.
Intervention: Stent retriever endovascular device for thrombectomy (Device)
Thrombectomy
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.
Intervention: Intravenous thrombolysis by alteplase (Actilyse) (optional) (Drug)
Control
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.
Intervention: Intravenous thrombolysis by alteplase (Actilyse) (optional) (Drug)
Outcomes
Primary Outcomes
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
- Length of in-hospital stay(90 (76-104) days after stroke onset)
- Recanalisation of the occluded artery for thrombectomy treated population(6h)
- Recanalisation of the occluded artery at 24h computerized tomography angiography /contrast-enhanced magnetic resonance angiography(22-36h)
- Distal embolism/reocclusion demonstrated by follow-up computerized tomography angiography /contrast-enhanced magnetic resonance angiography(22-36h)
- Embolism into new territories (ENT)(22-36h)
- 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)
- Recurrent stroke within 3 months(90 (76-104) days after stroke onset)
- Time to revascularisation(6h)
- Proportion of patients with recanalisation before thrombectomy(6h)
- Neurological and functional improvement in relation to thrombus length(90 (76-104) days)
- Neurological death within 7 days post treatment(7 days)
- All-cause mortality at 3 months(90 (76-104) days)
- Home time stay(90 (76-104) days after stroke onset)
- Reduction of infarct size(22-36h)
Investigators
Nils Wahlgren, MD, PhD, FESO
Professor of Neurology
Karolinska Institutet