Status:
TERMINATED
Feasibility Study of IV Recombinant Tissue Plasminogen Activator (rtPA) vs. Primary Endovascular Therapy for Acute Ischemic Stroke
Lead Sponsor:
Mayo Clinic
Conditions:
Stroke
Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01869478
Start Date
January 1 2013
End Date
September 1 2015
Last Update
October 5 2016
Active Locations (1)
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1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224