REstoring Flow by REvascularization With Submaximal Angioplasty in Hemodynamic IntraCranial Atherosclerotic Stenosis

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.

NCT Number	NCT03729817
Lead Sponsor	Case Western Reserve University
Conditions	Intracranial Atherosclerotic Disease, Stroke, Angioplasty, Balloon, Hemodynamics, Device Safety
Enrollment	159 participants
Start Date	2027-10
Primary Completion	2031-10-31 (estimated)
Study Completion	2032-10-31 (estimated)
Updated on ClinicalTrials.gov	2025-11-04