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NCT03094715: Tension

Efficacy and Safety of Thrombectomy in Stroke With Extended Lesion and Extended Time Window

Terminated NA Last updated 5 December 2023
What this trial tests

NA trial testing Thrombectomy in Stroke, Acute in 253 participants. Terminated before completion.

Timeline
20 June 2018
Primary endpoint
31 May 2023
15 November 2023

Quick facts

Lead sponsorUniversity Hospital Heidelberg
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment253
Start date20 June 2018
Primary completion31 May 2023
Estimated completion15 November 2023
Sites42 locations across Denmark, France, Slovakia, Austria, Germany, Norway, Canada, Switzerland

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital Heidelberg

Who can join

18 and older, any sex, with Stroke, Acute or Cerebral Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

TENSION (Efficacy and safety of ThrombEctomy iN Stroke with extended leSION and extended time window) is a prospective, open label, blinded endpoint (PROBE), European two-arm, randomized, controlled, post-market study to compare the safety and effectiveness of endovascular thrombectomy as compared to best medical care alone in the treatment of acute ischemic stroke patients with extended stroke lesions defined by an Alberta Stroke Program Early CT Score (ASPECTS) score of 3-5 and in an extended time window (up to 12 hours or unknown time of symptom onset). Up to 665 subjects will be randomized. Primary endpoint will be functional outcome assessed by the modified Rankin scale at 90 days post-stroke ("mRS shift analysis"). By this, TENSION will provide evidence of efficacy and safety of thrombectomy in an acute stroke population with uncertain benefit of endovascular stroke treatment.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial.
    Bendszus M, Fiehler J, Subtil F, Bonekamp S, et al · · 2023 · cited 360× · PMID 37837989 · DOI 10.1016/s0140-6736(23)02032-9
  2. Pathophysiology of Blood-Brain Barrier Permeability Throughout the Different Stages of Ischemic Stroke and Its Implication on Hemorrhagic Transformation and Recovery.
    Bernardo-Castro S, Sousa JA, Brás A, Cecília C, et al · · 2020 · cited 258× · PMID 33362697 · DOI 10.3389/fneur.2020.594672
  3. Mechanical Thrombectomy in Ischemic Stroke Patients With Alberta Stroke Program Early Computed Tomography Score 0-5.
    Kaesmacher J, Chaloulos-Iakovidis P, Panos L, Mordasini P, et al · · 2019 · cited 93× · PMID 30827193 · DOI 10.1161/strokeaha.118.023465
  4. Mechanical Thrombectomy for Large Ischemic Stroke: A Systematic Review and Meta-analysis.
    Li Q, Abdalkader M, Siegler JE, Yaghi S, et al · · 2023 · cited 89× · PMID 37277200 · DOI 10.1212/wnl.0000000000207536
  5. Acute ischaemic stroke: recent advances in reperfusion treatment.
    Widimsky P, Snyder K, Sulzenko J, Hopkins LN, et al · · 2023 · cited 82× · PMID 36477996 · DOI 10.1093/eurheartj/ehac684
  6. A randomized controlled trial to test efficacy and safety of thrombectomy in stroke with extended lesion and extended time window.
    Bendszus M, Bonekamp S, Berge E, Boutitie F, et al · · 2019 · cited 69× · PMID 30156479 · DOI 10.1177/1747493018798558
  7. Intracranial Hemorrhage After Reperfusion Therapies in Acute Ischemic Stroke Patients.
    Maïer B, Desilles JP, Mazighi M. · · 2020 · cited 64× · PMID 33362701 · DOI 10.3389/fneur.2020.599908
  8. Cerebral Edema in Patients With Large Hemispheric Infarct Undergoing Reperfusion Treatment: A HERMES Meta-Analysis.
    Ng FC, Yassi N, Sharma G, Brown SB, et al · · 2021 · cited 62× · PMID 34384229 · DOI 10.1161/strokeaha.120.033246

Verify or expand the search:

Other trials of Thrombectomy

Trials testing the same drug.

Other recruiting trials for Stroke, Acute

Currently open trials in the same condition.

Other University Hospital Heidelberg trials

Trials by the same sponsor.

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