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

Not yet recruiting

Phase N/A Results N/A

Trial 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 714 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.

Detailed Description

This study 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 (AIS) in patients with extended stroke lesions defined by an ASPECT score of 3-5 and in an extended time window (up to 12 hours, or unknown time of symptom onset). This is an adaptive design study, with prospectively stated interim analyses with specified stopping rules allowing for the possibility early termination based on either a determination of study success or futility.
Up to 714 subjects will be enrolled in the study and randomized for the Intention to treat analysis set. The randomization will be stratified by time from symptom onset (0-6h and 6-11h/wake up stroke), and stroke severity (NIHSS ≤18, NIHSS >18).
Interim data analysis is planned after the primary endpoint has been obtained for one third and two thirds of the patients. At each of these sample sizes, the available 90-day mRS data for each treatment arm will be evaluated. Safety interim analysis will be performed after one third and two thirds of the patients have been included.
Subjects who meet the inclusion criteria will be randomized in a 1:1 ratio to one of the following two treatment arms:
Arm 1: best medical care Arm 2: endovascular thrombectomy and best medical care The primary objective of this study is to test efficacy and safety of thrombectomy in acute stroke patients with uncertain benefit of endovascular stroke treatment, i.e. extended ischemic lesion size with an ASPECT score of 3-5 or late (up to 12 hours) or unknown time window as compared to best medical care alone.
Approximately 40 sites in Up to 20 sites in 8-10 European countries Patients presenting with acute ischemic stroke (AIS) based on focal occlusion in the M1 segment of the middle cerebral artery (MCA), and/or the intracranial segment of the distal internal carotid artery (ICA), determined by Magnetic Resonance Angiography (MRA) or Computed Tomographic Angiography (CTA), and who meet all eligibility criteria will be considered for study enrollment.

Conditions

Interventions

  • Thrombectomy Device
    Other Names: Mechanical thrombectomy
    Intervention Desc: Mechanical thrombectomy with state of the art thrombectomy devices (i.e. stent-retrievers, aspiration catheters). Devices will be used per instructions for use (IFU).
    ARM 1: Kind: Experimental
    Label: Thrombectomy
    Description: Endovascular thrombectomy and best medical care
  • Best medical care Other
    Other Names: Control group
    Intervention Desc: Best medical treatment will be performed as detailed in established Standard Operating Procedures, following regional guidelines (American Heart Association (AHA), European Stroke Organisation (ESO), Deutsche Schlaganfall-Gesellschaft (DSG), local country, etc.). If applicable, the reason for iv tissue plasminogen activator (tPA) ineligibility has to be documented on the eCRF.
    ARM 1: Kind: Experimental
    Label: Best medical care
    Description: Best medical treatment

Outcomes

Type Measure Time Frame Safety Issue
Primary Clinical outcome-modified Rankin Scale at 90 days 90 days
Secondary Independence - modified Rankin Scale≤2 at 90 days 90 days
Secondary Moderate Outcome - modified Rankin Scale≤3 at 90 days 90 days
Secondary Infarct volume 24 hours post procedure 18-36 hours
Secondary Infarct growth 18-36 hours
Secondary Functional neurological outcome at 12 months - modified Rankin Scale 12 month
Secondary Quality of life - PROMIS-10 and EQ-5D 90 days - 12 month
Secondary Post-stroke depression - PHQ-4 90 days - 12 month
Secondary Parenchymal hemorrhage type 2 90 days
Secondary modified Rankin Scale between 4-6 12 month
Secondary Frequencies of Adverse Events (AE) in both treatment arms within the first 7 days 12 month
Secondary Serious AEs 12 month
Secondary Space-occupying infarction 18-36 hours
Secondary New ischemic stroke 12 month
Secondary Symptomatic intracranial hemorrhage (sICH) at 24 (18-36) hours (CT or MRI) 18-36 hours
Secondary Cost Utility Assessment 12 month

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