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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor: Case Western Reserve University
Study ID: NCT03729817
Status: Not Yet Recruiting

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Conditions

Angioplasty, Balloon
Device Safety
Hemodynamics
Intracranial Atherosclerotic Disease
Stroke

Eligibility Criteria

Sex: ALL
Age: 30 Years - 90 Years
Healthy Volunteers: Not accepted

Interventions

Submaximal balloon angioplasty — DEVICE
An 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.

Study Details

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.