Objective Primary stenting for acute ischemic stroke (AIS) using the Wingspan stent delivery system has been reported. Major technical limitations in that study were difficulties in delivering the device and a few cases in which the Enterprise vascular reconstruction device (stent) was used as a bailout procedure. The Enterprise, which has relatively less radial force and more flexibility than other intracranial stents, is an ideal device for revascularization as it is easily delivered through tortuous intracranial vessels. We tested the safety and effectiveness of this stent as the primary revascularization device for AIS in an FDA-approved investigational device exemption prospective cohort study.
Methods Twenty patients presenting with AIS due to confirmed intracranial large vessel occlusion within 8 h of onset of stroke symptoms were treated with the Enterprise as the primary revascularization device. The primary outcome was recanalization to Thrombolysis In Myocardial Infarction (TIMI) flow of ≥2. Perioperative safety was measured by major complication incidence within 30 days of stent revascularization. A secondary measure of outcome was 30-day modified Rankin Scale (mRS) score.
Results Recanalization to TIMI 2 (n=6) or 3 (n=12) flow was achieved in 18 patients (90% revascularization rate). Three major complications were noted (15%) including one myocardial infarction, one symptomatic intracranial hemorrhage and one ischemic stroke in a distribution other than the qualifying vessel. Good outcome (mRS ≤2) was obtained in 10 patients (50%).
Conclusions In this prospective study the Enterprise stent was found to be a safe and effective revascularization tool in the setting of AIS.
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