Endovascular treatment for acute ischemic stroke in the Netherlands

Not Applicable

Completed

• Conditions: Acute ischemic stroke, caused by intracranial proximal arterial occlusion (anterior circulation); Circulatory System; Stroke, not specified as haemorrhage or infarction

• Registration Number: ISRCTN10888758
• Lead Sponsor: Dutch Heart Foundation (Netherlands)

Brief Summary

2014 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/25179366 protocol 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25517348 results 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26903582 results 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27302238 results 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27421546 results 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27491736 results 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27601379 results 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27827328 results 2017 Results article in http://www.ncbi.nlm.nih.gov/pubmed/28379802 results 2017 Results article in http://www.ncbi.nlm.nih.gov/pubmed/28351963 results 2017 Results article in http://www.ncbi.nlm.nih.gov/pubmed/28389610 results 2017 Results article in http://www.ncbi.nlm.nih.gov/pubmed/28531910 results 2017 Results article in http://www.ncbi.nlm.nih.gov/pubmed/28432266 results 2017 Results article in http://www.ncbi.nlm.nih.gov/pubmed/28436305 results 2018 Results article in http://www.ncbi.nlm.nih.gov/pubmed/28404769 results 2018 Results article in http://www.ncbi.nlm.nih.gov/pubmed/29321337 results 2018 Results article in http://www.ncbi.nlm.nih.gov/pubmed/28799861 results 2018 Results article in http://www.ncbi.nlm.nih.gov/pubmed/29040040 results 2018 Results article in http://www.ncbi.nlm.nih.gov/pubmed/29365017 results 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30571406 results 2019 Results article in http://www.ncbi.nlm.nih.gov/pubmed/30297537 results 2019 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/31825939 post hoc analysis (added 12/12/2019) 2021 Abstract results in https://pubmed.ncbi.nlm.nih.gov/34645287/ Economic evaluation (added 15/10/2021) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35674042/ retrospective analysis (added 09/06/2022) 2021 Abstract results in https://doi.org/10.1177/23969873211034932 Results abstract European Stroke Organisation Conference 2021 (added 29/03/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/38102770/ Multivessel occlusions (MVO) (added 18/12/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-24
• Study Completion: 2015-01-01
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. A clinical diagnosis of acute stroke, with a deficit on the National Institutes of Health (NIH) stroke scale of 2 points or more
2. Computerised tomography (CT) or magnetic resonance imaging (MRI) scan ruling out intracranial hemorrhage
3. Intracranial arterial occlusion of the distal intracranial carotid artery or middle (M1/M2) or anterior (A1/A2) cerebral artery, demonstrated with Computed Tomography Angiography (CTA), magnetic resonance angiography (MRA), Digital subtraction angiography (DSA) or transcranial Doppler/duplex (TCD)
4. The possibility to start treatment within 6 hours from onset
5. Informed consent given
6. Age 18 or over

Exclusion Criteria

General:
1. Arterial blood pressure > 185/110 mmHg
2. Blood glucose < 2.7 or > 22.2 mmol/L
3. Intravenous treatment with thrombolytic therapy in a dose exceeding 0.9 mg/kg alteplase or 90 mg
4. Intravenous treatment with thrombolytic therapy despite contra-indications, i.e. major surgery, gastrointestinal bleeding or urinary tract bleeding within the previous 2 weeks, or arterial puncture at a non-compressible site within the previous 7 days

For Intended mechanical thrombectomy:
Laboratory evidence of coagulation abnormalities, i.e. platelet count <40 x 109/L, activated partial thromboplastin time (APTT)>50 sec or International Normalised Ratio (INR) >3.0.

For intended intra-arterial thrombolysis:
1. Cerebral infarction in the distribution of the relevant occluded artery in the previous 6 weeks
2. History of intracerebral hemorrhage
3. Severe head injury (contusion) in the previous 4 weeks
4. Clinical or laboratory evidence of coagulation abnormalities, i.e. platelet count <90 x 109/L, APTT>50 sec or INR >1.7

Study & Design

• Study Type: Interventional
• Study Design: Not specified