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| Name | Class |
|---|---|
| Swedish Heart Lung Foundation | OTHER |
| Medtronic - MITG | INDUSTRY |
| Stryker Nordic | INDUSTRY |
| Phenox GmbH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Excellent recovery at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | 17176 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33563015 | Derived | 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. |
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| 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) |
|
|
Proportion of patients with excellent outcome (mRS score 0-1) at 3 months
| 90 (76-104) days after stroke onset |
| 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 |
| 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 |
| Recurrent stroke within 3 months | 90 (76-104) days after stroke onset |
| 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 |
| 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 |
| Recanalisation of the occluded artery at 24h computerized tomography angiography /contrast-enhanced magnetic resonance angiography | Defined as AOL 2-3 | 22-36h |
| Proportion of patients with recanalisation before thrombectomy | Defined as AOL 2-3 | 6h |
| Reduction of infarct size | Reduction in infarct size (thrombectomy vs. control) at 22-36 hours | 22-36h |
| 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 |
| All-cause mortality at 3 months | 90 (76-104) days |
| Neurological death within 7 days post treatment | 7 days |
| 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 |
| Embolism into new territories (ENT) | 22-36h |
| 22-36 h |
| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| D002545 | Brain Ischemia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017131 | Thrombectomy |
| D010959 | Tissue Plasminogen Activator |
| ID | Term |
|---|---|
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |
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