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.
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.
- 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
|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|