A randomized controlled trial to test efficacy and safety of thrombectomy in stroke with extended lesion and extended time window
Language English Country United States Media print-electronic
Document type Clinical Trial Protocol, Journal Article, Research Support, Non-U.S. Gov't
PubMed
30156479
PubMed Central
PMC6604397
DOI
10.1177/1747493018798558
Knihovny.cz E-resources
- Keywords
- Acute stroke therapy, intervention, ischemic stroke, protocols, radiology, stroke, therapy, treatment,
- MeSH
- Survival Analysis MeSH
- Time Factors MeSH
- Stroke * mortality surgery therapy MeSH
- Adult MeSH
- Endovascular Procedures MeSH
- Fibrinolytic Agents therapeutic use MeSH
- Brain Ischemia * mortality surgery therapy MeSH
- Middle Aged MeSH
- Humans MeSH
- Young Adult MeSH
- Tomography, X-Ray Computed MeSH
- Disease Progression MeSH
- Randomized Controlled Trials as Topic MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Severity of Illness Index MeSH
- Thrombectomy * MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Young Adult MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Clinical Trial Protocol MeSH
- Geographicals
- Europe MeSH
- Names of Substances
- Fibrinolytic Agents 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
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ClinicalTrials.gov
NCT03094715
