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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intracranial Vasospasm
- Sponsor
- Yonsei University
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Assess the safety (adverse events) of the interventional procedure.
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief 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
Detailed Description
Prospective exploratory study, single arm (off label), single center study 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients≥ 19 years
- •Radiologic confirmed refractory intracranial vasospasm or due to subarachnoid hemorrhage (caused by trauma, aneurysmal rupture, spontaneous, etc.) or suspected recurrent intracrania vasospasm with the following radiological/clinical evidence (\* refractory intracranial vasospasm: despite of standard treatment ≥ 50% decrease in vessel diameter compared to first angiography)
- •recurrent intracrania vasospasm: Even though chemical angioplasty was performed, radiologically cerebral vasospasm worsens (severe cerebral vasospasm(70-99%)) with worsening clinical symptoms.
- •Individuals who voluntarily signed the informed consent form to participate in this study.
Exclusion Criteria
- •Pre-existing intracranial stenosis ≥ 50%
- •Patients whose condition makes further evaluation and procedures difficult
- •Exclude if Hunt and Hess grade is 4 or higher.
- •Difficult vascular access
- •History of vascular malformation, vascular anastomosis, or stent placement.
- •Distal location: Middle cerebral artery (MCA) segment M3 or below, anterior cerebral artery (ACA) segment A3 or below, posterior cerebral artery (PCA) segments P3 or P4 or below.
- •Cerebral vasospasm caused by vasculitis or dissection.
- •Hypersensitivity to medications to be used (contrast agents, vasodilators..).
- •Pregnancy or breastfeeding.
- •History of connective tissue disease or blood coagulation disorders.
Outcomes
Primary Outcomes
Assess the safety (adverse events) of the interventional procedure.
Time Frame: at 24 hours and 72 hours after the intervention at 3 months after Cerebral Vasospasm Onset.
Secondary Outcomes
- Intervention Success Rate(at 24 hours and 72 hours after the intervention at 3 months after Cerebral Vasospasm Onset.)
- Whether additional treatment is required after intervention (; in relation to cerebral vasospasm) questionnaire(On the 1 day of the subject's intervention)
- Symptom Improvement (NIHSS)(Improvement in NIHSS at 3 months after Cerebral Vasospasm Onset.)
- Clinical Improvement (mRS)(at 24 hours and 72 hours after the intervention at 3 months after Cerebral Vasospasm Onset.)
- Degree of Cerebral Vasospasm(observed in CT cerebral angiography at 24 hours and 72 hours after the intervention.)