A randomized controlled trial to test efficacy and safety of
thrombectomy in stroke with extended lesion and extended time
window

J 2019

A randomized controlled trial to test efficacy and safety of thrombectomy in stroke with extended lesion and extended time window

BENDSZUS, M., S. BONEKAMP, E. BERGE, F. BOUTITIE, P. BROUWER et. al.

Základní údaje

Originální název

A randomized controlled trial to test efficacy and safety of thrombectomy in stroke with extended lesion and extended time window

Autoři

BENDSZUS, M., S. BONEKAMP, E. BERGE, F. BOUTITIE, P. BROUWER, E. GIZEWSKI, A. KRAJINA, L. PIEROT, G. RANDALL, C. Z. SIMONSEN, K. ZELENAK, J. FIEHLER a G. THOMALLA

Vydání

International Journal of Stroke, Hoboken, Wiley-Blackwell, 2019, 1747-4930

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30230 Other clinical medicine subjects

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 4.882

DOI

http://dx.doi.org/10.1177/1747493018798558

UT WoS

000453594400014

Klíčová slova česky

Acute stroke therapy; intervention; ischemic stroke; protocols; radiology; stroke; therapy; treatment

Klíčová slova anglicky

Acute stroke therapy; intervention; ischemic stroke; protocols; radiology; stroke; therapy; treatment

Štítky

Excelence Science, FN HK, RIV, user

Změněno: 7. 12. 2021 13:04, Bc. Hana Vladíková, BBA

Anotace

V originále

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).

Návaznosti

90090, velká výzkumná infrastruktura

Název: CZECRIN II

Citovat

BENDSZUS, M., S. BONEKAMP, E. BERGE, F. BOUTITIE, P. BROUWER, E. GIZEWSKI, A. KRAJINA, L. PIEROT, G. RANDALL, C. Z. SIMONSEN, K. ZELENAK, J. FIEHLER a G. THOMALLA. A randomized controlled trial to test efficacy and safety of thrombectomy in stroke with extended lesion and extended time window. International Journal of Stroke. Hoboken: Wiley-Blackwell, 2019, roč. 14, č. 1, s. 87-93. ISSN 1747-4930. Dostupné z: https://dx.doi.org/10.1177/1747493018798558.

@article{1808017,
   author = {Bendszus, M. and Bonekamp, S. and Berge, E. and Boutitie, F. and Brouwer, P. and Gizewski, E. and Krajina, A. and Pierot, L. and Randall, G. and Simonsen, C. Z. and Zelenak, K. and Fiehler, J. and Thomalla, G.},
   article_location = {Hoboken},
   article_number = {1},
   doi = {http://dx.doi.org/10.1177/1747493018798558},
   keywords = {Acute stroke therapy; intervention; ischemic stroke; protocols; radiology; stroke; therapy; treatment},
   language = {eng},
   issn = {1747-4930},
   journal = {International Journal of Stroke},
   note = {RIV/00179906:_____/19:10398982!RIV20-MZ0-00179906},
   title = {A randomized controlled trial to test efficacy and safety of thrombectomy in stroke with extended lesion and extended time window},
   url = {https://journals.sagepub.com/doi/10.1177/1747493018798558},
   volume = {14},
   year = {2019}
}

TY  - JOUR
ID  - 1808017
AU  - Bendszus, M. - Bonekamp, S. - Berge, E. - Boutitie, F. - Brouwer, P. - Gizewski, E. - Krajina, A. - Pierot, L. - Randall, G. - Simonsen, C. Z. - Zelenak, K. - Fiehler, J. - Thomalla, G.
PY  - 2019
TI  - A randomized controlled trial to test efficacy and safety of thrombectomy in stroke with extended lesion and extended time window
JF  - International Journal of Stroke
VL  - 14
IS  - 1
SP  - 87-93
EP  - 87-93
PB  - Wiley-Blackwell
SN  - 17474930
N1  - RIV/00179906:_____/19:10398982!RIV20-MZ0-00179906
KW  - Acute stroke therapy
KW  - intervention
KW  - ischemic stroke
KW  - protocols
KW  - radiology
KW  - stroke
KW  - therapy
KW  - treatment
UR  - https://journals.sagepub.com/doi/10.1177/1747493018798558
N2  - 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).
ER  -

BENDSZUS, M., S. BONEKAMP, E. BERGE, F. BOUTITIE, P. BROUWER, E. GIZEWSKI, A. KRAJINA, L. PIEROT, G. RANDALL, C. Z. SIMONSEN, K. ZELENAK, J. FIEHLER a G. THOMALLA. A randomized controlled trial to test efficacy and safety of thrombectomy in stroke with extended lesion and extended time window. \textit{International Journal of Stroke}. Hoboken: Wiley-Blackwell, 2019, roč.~14, č.~1, s.~87-93. ISSN~1747-4930. Dostupné z: https://dx.doi.org/10.1177/1747493018798558.

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