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NOT YET RECRUITING
NCT03729817
NA

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

Sponsor: Case Western Reserve University

View on ClinicalTrials.gov

Summary

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.

Official title: VERiTAS-2 REFRESH ICAS (REstoring Flow by REvascularization With Submaximal Angioplasty in Hemodynamic IntraCranial Atherosclerotic Stenosis)

Key Details

Gender

All

Age Range

30 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

159

Start Date

2027-10

Completion Date

2032-10-31

Last Updated

2025-11-04

Healthy Volunteers

No

Interventions

DEVICE

Submaximal balloon angioplasty

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.

Locations (1)

Case Western Reserve University

Cleveland, Ohio, United States