Stroke, Ischemic Stroke
Conditions
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 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.
Interventions
DEVICEEndovascular Arterial Reperfusion
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recanalization Rate of Primary Intracranial Occlusion | 24 hours | The degree of recanalization (none, partial, complete) will be assessed in a blinded fashion on the 24-hour computed tomographic angiogram (CTA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Score on Modified Rankin Scale at 90 Days | 90 days | Functional outcome at 90-days will be assessed with the modified Rankin Scale (mRS). The Modified Rankin Scale was completed by the physician; it is a 7 point scale rating any limitations in the study subject's social role. The scale ranges from 0 (no symptoms/disability) to 6 (death). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intravenous Thrombolysis 0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes. | 0 |
| Endovascular Arterial Reperfusion Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Endovascular Arterial Reperfusion | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 participants | 0 participants |
| Age, Categorical >=65 years | 0 participants | 0 participants |
| Age, Categorical Between 18 and 65 years | 1 participants | 1 participants |
| Gender Female | 1 participants | 1 participants |
| Gender Male | 0 participants | 0 participants |
| Region of Enrollment United States | 1 participants | 1 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 1 |
| serious Total, serious adverse events | 0 / 0 | 0 / 1 |
Outcome results
Primary
Recanalization Rate of Primary Intracranial Occlusion
The degree of recanalization (none, partial, complete) will be assessed in a blinded fashion on the 24-hour computed tomographic angiogram (CTA).
Time frame: 24 hours
Population: Only one participant was enrolled, so data analysis was not possible.
Secondary
Mean Score on Modified Rankin Scale at 90 Days
Functional outcome at 90-days will be assessed with the modified Rankin Scale (mRS). The Modified Rankin Scale was completed by the physician; it is a 7 point scale rating any limitations in the study subject's social role. The scale ranges from 0 (no symptoms/disability) to 6 (death).
Time frame: 90 days
Population: Only one participant was enrolled, so data analysis was not possible.