By assessing the safety and durability of an endovascular intervention, this study will justify and inform the design of a subsequent seamless feasibility/pivotal trial aimed at the treatment of intracranial atherosclerotic stenosis (ICAS), an entity which carries a high risk of stroke despite existing medical therapies, and has no other treatment options. Given the global burden of ICAS as a leading cause of stroke, there is a high potential for public health impact not just in the U.S., but world-wide.
Non-severe recent stroke (within 30 days) attributed to 70-99% stenosis of intracranial artery (internal carotid, middle cerebral, vertebral, basilar); must be confirmed by CTA (or DSA if already available) for enrollment into the trial.
Hemodynamic compromise based on borderzone infarct pattern* for the anterior circulation (internal carotid and middle cerebral artery stenosis) and by low flow state on QMRA** for the posterior circulation (vertebral and basilar artery stenosis).
Target vessel with minimal nominal diameter of 2mm
Target length of stenosis <18mm
None