Purpose: Based on the results of SAMMPRIS trial, modifications in patient selection and procedural aspects for intracranial stent placement have been recommended. We performed a multicenter prospective single arm trial to determine if such modifications will result in lower rates of peri-procedural stroke and/or death.
Materials and Methods: The study enrolled patients with recent transient ischemic attack or ischemic stroke (excluding lacunar ischemic events) related to high-grade (70-99% in severity) stenosis of a major intracranial artery. Patients were treated using angioplasty and self-expanding stent after 3 weeks of index ischemic event at one of the 10 high volume centers in China. An independent neurologist ascertained the occurrence of any stroke and/or death within one month after the procedure.
Results: A total of 100 consecutive patients were recruited. The target lesions were located in middle cerebral artery [M1] (n=38, 38%), intracranial internal carotid artery (n=17, 17%), intradural vertebral artery (n=18, 18%), and basilar artery (n=27, 27%). The technical success rate of stent deployment with residual stenosis <50% was 100%. The overall one-month stroke and/or death rate was 2% (95% confidence interval 0.7% - 4.7%). Two ischemic strokes occurred in pontine region (perforator distribution) in patients following angioplasty and stent placement for basilar artery stenosis.
Conclusion: The results of this prospective multi-center study demonstrated that modifications in patient selection and procedural aspects can substantially reduce the one-month stroke and/or death rate following intracranial stent placement.