Feasibility Study of IV Recombinant Tissue Plasminogen Activator (rtPA) vs. Primary Endovascular Therapy for Acute Ischemic Stroke
Feasibility Study of IV Recombinant Tissue Plasminogen Activator (rtPA) vs. Primary Endovascular Therapy for Acute Ischemic Stroke
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.
Inclusion Criteria:

 -  Age ≥ 18 years

 -  Definite or probable ischemic stroke

 -  CT angiographic (CTA) evidence of intracranial vascular occlusion (internal carotid,
 middle cerebral - M1 or M2 divisions, anterior cerebral, posterior cerebral, or
 basilar artery) within 3.5 hours of symptom onset

 -  Able to receive assigned treatment within 4.5 hours of symptom onset

 -  Written informed consent from patient or surrogate, if unable to provide consent

 Exclusion Criteria:

 -  CT evidence of early infarction in >1/3 of middle cerebral artery distribution

 -  Blood pressure > 185/110 mmHg refractory to anti-hypertensive therapy

 -  History of intracranial hemorrhage

 -  History of ischemic stroke within past 3 months

 -  History of major surgical procedure within past 14 days

 -  Gastrointestinal or genitourinary bleeding within past 14 days

 -  Glucose <50 or >400mg/dL

 -  Platelet count <100,000

 -  International normalized ratio (INR) ≥ 1.7

 -  Known history of bleeding diathesis