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Mechanical Intracranial Artery DilAtation Using Stent-retriever for Cerebral Vasospasm
Sponsor: Yonsei University
Summary
Solitaire-x is a stent-retriever that is currently world-widely used, but is currently FDA-approved only as a revascularization device indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke. Its utility for mechanical endovascular dilatation for refractory intracranial vasospasm is an off-label indication. In this reason, we designed single-arm, prospective study, which aimed to report the safety and effectiveness of Solitaire-X in CV after subarachnoid Prospective exploratory study, single arm (off label), single center study
Official title: An Exploratory Study of Intra-arterial Mechanical Angioplasty Using a SOLITAIRE™ X Stent for Refractory and Recurrent Vasospasm Mechanical Intracranial Artery DilAtation Using Stent-retriever for Cerebral Vasospasm
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2024-09
Completion Date
2027-04
Last Updated
2024-09-27
Healthy Volunteers
No
Conditions
Interventions
stent-angioplasty & nimodipine infusion (During the stent (Solitaire-X) -angioplasty, IA nimodipine was also infused)
I. Procedure \& Intervention 1. Assess the presence and degree of cerebral vasospasm of the target vessel through cerebral angiography before the procedure. 2. Solitaire-X stent types are selected 3. During the stent-angioplasty, IA nimodipine was also infused. 4. Retrieve Solitaire-X after maintaining deployment for 3 minutes. 5. Additional procedures are determined through immediate post-procedure and 15-minute delayed cerebral angiography.
Locations (1)
Yonsei university college of medicine
Seoul, South Korea