An interventional study of stent-angioplasty & nimodipine infusion (During the stent (Solitaire-X) -angioplasty, IA nimodipine was also infused) in Intracranial Vasospasm, sponsored by Yonsei University. Not yet recruiting at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-27.
Sponsored by Yonsei University · Not applicable, Interventional, and Treatment
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
Prospective exploratory study, single arm (off label), single center study I. Procedure \& Intervention
77 studies on the registry are indexed under Vasospasm, Intracranial; 15 are open to participants now.
This study's planned enrollment of 10 is below the median of 25 across 51 interventional studies indexed under Vasospasm, Intracranial.
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Patients≥ 19 years 2. 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.
Exclusion Criteria:
History of vascular malformation, vascular anastomosis, or stent placement. 4. 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.
During the stent (Solitaire-X) -angioplasty, IA nimodipine was also infused
Device: 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.
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.
Intervention Success Rate
Recovery of more than 50% of the pre-procedure vessel diameter, measured at 24 hours and 72 hours after the intervention.
Time frame: 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
Time frame: On the 1 day of the subject's intervention
Symptom Improvement (NIHSS)
NIHSS: National Institutes of Health Stroke Scale Score 0: no stroke Score 1-4: minor stroke Score 5-15: moderate stroke Score 15-20: moderate to severe stroke Score 21-42: severe stroke
Time frame: Improvement in NIHSS at 3 months after Cerebral Vasospasm Onset.
Clinical Improvement (mRS)
mRS: Modified Rankin Score 0: None 1. No significant disability despite symptoms: able to carry out all usual duties and activities 2. Slight disability: unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability: requiring some help, but able to walk without assistance 4. Moderately severe disability: unable to walk without assistance, unable to attend to needs without assistance 5. Severe disability: bed-ridden, incontinent, and requiring constant nursing care and attention 6. Dead
Time frame: at 24 hours and 72 hours after the intervention at 3 months after Cerebral Vasospasm Onset.
Degree of Cerebral Vasospasm
* Visual classification: Cerebral vasospasm grades (CVSG). Grade 0 All intracranial vessels show a physiological shape Grade 1 Vasospasm affects the A2, A1, and M2 segments Grade 2 Vasospasm expands to the M1 and terminal segment of the internal carotid artery Grade 3 Severe reduction in the intradural internal carotid artery with filiform A1 and M1 segments, which sometimes appears like a ghost (ghost sign) * Degree of diameter reduction * None (0-10%), * Mild (11-49%), * Moderate (50-69%), * Severe (70-99%)
Time frame: observed in CT cerebral angiography at 24 hours and 72 hours after the intervention.
Plan to share: No
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Yonsei University