Trial Summary
What is the purpose of this trial?
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.
Eligibility Criteria
This trial is for people aged 30-90 with a recent, non-severe stroke due to 70-99% blockage in certain brain arteries. They must have specific risk factors or diseases in other blood vessels if they're under 50. Exclusions include major strokes, conditions that could affect the study's results, very short life expectancy, certain heart and blood disorders, and previous treatments on the target area.Inclusion Criteria
I have experienced symptoms within the last 30 days.
I had a mild stroke within the last month due to a narrowed brain artery.
You have low blood flow, as determined by a specific test used in the VERiTAS Study.
See 7 more
Exclusion Criteria
I need blood thinners for a clot or irregular heartbeat beyond joining the study.
I do not have any brain or nerve conditions that could affect my study results.
I am allergic to or cannot take aspirin or Plavix.
See 15 more
Treatment Details
Interventions
- Intensive medical therapy (Other)
- Submaximal balloon angioplasty (Angioplasty)
Trial OverviewThe trial tests submaximal balloon angioplasty's safety and effectiveness for treating intracranial atherosclerotic stenosis (ICAS), which can lead to strokes. It aims to support future larger trials by providing initial data on this technique as an alternative when medical therapy isn't enough.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Submaximal balloon angioplasty plus intensive medical therapyExperimental Treatment1 Intervention
Endovascular intervention with submaximal balloon angioplasty
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University oif Illinois at ChicagoChicago, IL
Case Western Reserve UniversityCleveland, OH
Loading ...
Who Is Running the Clinical Trial?
University of Illinois at ChicagoLead Sponsor
Case Western Reserve UniversityLead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)Collaborator