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
Single group
Submaximal balloon angioplasty
DeviceAn endovascular procedure involving inflation of a balloon catheter undersized to 50-75% of normal vessel diameter to perform angioplasty of a stenotic blood vessel segment, with the goal of increasing blood flow.
Procedural Safety
Any stroke (ischemic or hemorrhagic), or death, within 30 days following submaximal angioplasty
Clinical Efficacy
Any stroke/death within 30 days or ischemic stroke in the symptomatic vessel territory at one year
Hemodynamic Success
Initial hemodynamic effect of submaximal balloon angioplasty on treated vessel flow
Hemodynamic Durability
Hemodynamic durability of submaximal balloon angioplasty at follow-up in the treated vessel at follow-up
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
