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.

Basic information

Original name

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

Authors

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 and G. THOMALLA

Edition

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

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30230 Other clinical medicine subjects

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 4.882

DOI

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

UT WoS

000453594400014

Keywords (in Czech)

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

Keywords in English

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

Abstract

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).

Links

90090, large research infrastructures

Name: 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 and 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, vol. 14, No 1, p. 87-93. ISSN 1747-4930. Available from: 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 and 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, vol.~14, No~1, p.~87-93. ISSN~1747-4930. Available from: https://dx.doi.org/10.1177/1747493018798558.

Detailed Information on Publication Record