Extending the Time for Thrombolysis in Emergency Neurological Deficits - Intra-Arterial "EXTEND-IA"

Terminated

Phase 2 Results N/A

Trial Description

Patients presenting to the emergency department with acute ischaemic stroke, who are eligible for standard intravenous tPA therapy within 4.5 hours of stroke onset will be assessed for "dual target" major vessel occlusion and mismatch to determine their eligibility for randomisation into the trial. If the patient gives informed consent they will be randomised 50:50 using central computerised allocation to intra-arterial clot retrieval after IV tPA or IV tPA alone. The trial is prospective, randomised, open-label, blinded endpoint (PROBE) design.

Trial Stopped: On DSMB advice, trial recruitment has been halted for efficacy. F/U continues

Conditions

Interventions

  • Intra-arterial Clot Retrieval with Solitaire device Device
    Intervention Desc: Intra-arterial mechanical clot retrieval with the Solitaire device after patients have received standard therapy with intravenous tissue plasminogen activator (tPA). Clot retrieval involves cerebral angiography and takes approximately 2 hours.
    ARM 1: Kind: Experimental
    Label: Intra-arterial Clot Retrieval after iv tPA
  • Intravenous tissue plasminogen activator (tPA) Genetic
    Intervention Desc: Standard care IV tPA therapy administered as per registered product information
    ARM 1: Kind: Experimental
    Label: Standard care iv tPA

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Reperfusion at 24 hours (CT or MR perfusion imaging) 24 hours post stroke onset No
Primary Early neurological recovery at 24 hours (National Institutes of Health Stroke Score - NIHSS) 24 hours post stroke onset No
Secondary Reperfusion at 24 hrs post stroke without symptomatic intracerebral hemorrhage (CT or MR perfusion imaging) 24 hours post stroke onset Yes
Secondary Recanalisation at 24 hrs post stroke (CT or MR angiography) 24 hours post stroke onset No
Secondary Infarct growth within 24 hrs (CT and MRI) 24 hours post stroke onset No
Secondary Stroke severity (NIHSS) at day 3 3 days post stroke onset No
Secondary Symptomatic intra-cranial hemorrhage (ECASS type 2 parenchymal hematoma on CT or MRI combined with >/=4 point deterioration in NIHSS within 36 hours of treatment). within 36 hours of intervention Yes
Secondary Death due to any cause 3 months Yes
Secondary Modified Rankin Scale (mRS) 0-1 at 3 months 3 months No
Secondary Categorical shift in mRS at 3 months 3 months No
Secondary NIHSS reduction 8 points or reaching 0-1 at 3 months 3 months No
Primary Favourable clinical response at 3 days(National Institutes of Health Stroke Score - NIHSS) 3 days post stroke onset No
Secondary Stroke severity (NIHSS) at 24 hours 24 hours post stroke onset No
Secondary Modified Rankin Scale (mRS) 0-2 at 3 months 3 months No

Sponsors