A randomized controlled trial to test efficacy and safety of thrombectomy in stroke with extended lesion and extended time window
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu protokol klinické studie, časopisecké články, práce podpořená grantem
PubMed
30156479
PubMed Central
PMC6604397
DOI
10.1177/1747493018798558
Knihovny.cz E-zdroje
- Klíčová slova
- Acute stroke therapy, intervention, ischemic stroke, protocols, radiology, stroke, therapy, treatment,
- MeSH
- analýza přežití MeSH
- časové faktory MeSH
- cévní mozková příhoda * mortalita chirurgie terapie MeSH
- dospělí MeSH
- endovaskulární výkony MeSH
- fibrinolytika terapeutické užití MeSH
- ischemie mozku * mortalita chirurgie terapie MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- počítačová rentgenová tomografie MeSH
- progrese nemoci MeSH
- randomizované kontrolované studie jako téma MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- stupeň závažnosti nemoci MeSH
- trombektomie * MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- protokol klinické studie MeSH
- Geografické názvy
- Evropa MeSH
- Názvy látek
- fibrinolytika MeSH
RATIONALE: The benefit of thrombectomy in patients with intracranial large vessel occlusion of the anterior circulation has been shown in selected patients in previous randomized controlled trials, but patients with extended ischemic lesions were excluded in the majority of these trials. TENSION aims to demonstrate efficacy and safety of thrombectomy in patients with extended lesions in an extended time window (up to 12 h from onset or from last seen well). DESIGN: TENSION is an investigator-initiated, randomized controlled, open label, blinded endpoint, European, two-arm, postmarket study to compare the safety and effectiveness of thrombectomy as compared to best medical care alone in stroke patients with extended stroke lesions defined by an Alberta Stroke Program Early Computed Tomography Scan score of 3-5 and in an extended time window. In an adaptive design study, up to 665 patients will be randomized. OUTCOMES: Primary efficacy endpoint will be clinical outcome defined by the modified Rankin Scale at 90-day poststroke. The main safety endpoint will be death and dependency (modified Rankin Scale 4-6) at 90 days. Additional effect measures include adverse events, health-related quality of life, poststroke depression, and costs utility assessment. DISCUSSION: TENSION may make effective treatment available for patients with severe stroke in an extended time window, thereby improving functional outcome and quality of life of thousands of stroke patients and reducing the individual, societal, and economic burden of death and disability resulting from severe stroke. TENSION is registered at ClinicalTrials.gov (ClinicalTrials.gov Identifier NCT03094715).
Department of Internal Medicine and Cardiology Oslo University Hospital Oslo Norway
Department of Neurology Aarhus University Hospital Aarhus Denmark
Department of Neurology University of Hamburg Germany
Department of Neuroradiology Hôpital Maison Blanche Université Reims Champagne Ardenne Reims France
Department of Neuroradiology Karolinska University Hospital Stockholm Sweden
Department of Neuroradiology Medical University Innsbruck Austria
Department of Neuroradiology University of Hamburg Germany
Department of Neuroradiology University of Heidelberg Germany
Department of Radiology Charles University Hospital Hradec Kralove Czech Republic
Zobrazit více v PubMed
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ClinicalTrials.gov
NCT03094715
