This pilot trial will be the first step toward direct comparison of delivery of endovascular reperfusion therapy to intravenous recombinant tissue plasminogen activator (rt-PA) in a time-to-treatment framework shown as most effective by the NINDS rt-PA Stroke Trial. A randomized trial is justified for the following reasons: 1) The high rate of death and disability associated with ischemic stroke despite treatment with intravenous rt-PA mandates critical analysis of alternate therapies with therapeutic potential, 2) endovascular treatment for acute ischemic stroke is expanding in North America without compelling evidence of safety and efficacy from well-designed clinical trials, 3) critical cost-effectiveness analysis cannot be done without acquiring pertinent outcomes data from controlled studies.
Trial Stopped: Poor recruitment
- Intravenous Thrombolysis Drug
ARM 1: Kind: Experimental Label: Intravenous Thrombolysis Description: 0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.
- Endovascular Arterial Reperfusion Device
Other Names: Penumbra, Solitaire ARM 1: Kind: Experimental Label: Endovascular Arterial Reperfusion Description: Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.
- Allocation: Randomized
- Masking: Single Blind (Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Recanalization rate of primary intracranial occlusion||24 hours||No|
|Secondary||modified Rankin Scale||90 days||No|
|Secondary||Mean Score on Modified Rankin Scale at 90 Days||90 days||No|
- Mayo Clinic Lead