Abstract TP26: Enterprise™-assisted Recanalization in Acute Ischemic Stroke (ERAIS): First FDA approved prospective trial
AIM: The ERAIS study was designed to test the safety of the Enterprise stent as the primary intraarterial device in cerebral revascularization.
METHODS: Twenty patients with acute ischemic stroke within 8 hours of stroke symptom onset with contraindication to IV thrombolysis or with no clinical improvement 1 hour after administration of IV thrombolysis were prospectively enrolled between July 2010 and June 2012 after consultation with the local IRB and FDA. The Enterprise stent was deployed across the occlusion. Alternatively, the stent was used as a thrombectomy device based on operator preference.
RESULTS: All patients had major intracranial vessel occlusion (TIMI 0), with an average preoperative NIHSS score of 15.5±1.3. The primary target vessels where the stents were deployed were the MCA in 15 patients, ICA in 2, basilar artery in 2 and tandem ICA-MCA in 1.The stent was deployed in 13 patients and used as a thrombectomy device and thus retrieved in 7 patients. Twenty-four stents were used in 20 patients. The time from start of procedure to TIMI 2/3 recanalization was 43±21 minutes. Recanalization to TIMI 2/3 flow was achieved in 18 (90%) of 20 patients. Three major complications were noted (15%), including 2 MIs and 1 ischemic stroke in a distribution other than the qualifying vessel. Eight minor complications were noted. Seven (35%) patients died within 30 days of revascularization. Ten patients (50%) improved to an mRS score of 0-2 within 30 days post-intervention.
CONCLUSION: The Enterprise stent is equivalent in efficiency and has comparable acceptable adverse events when compared to previously published results with the Wingspan stent in the SARIS trial and confirms the high recanalization rate achieved with stent-assisted revascularization in selected patients. This is the first reported prospective FDA-approved trial with the Enterprise stent as the primary intraarterial stroke revascularization device.
- © 2012 by American Heart Association, Inc.