None listed
Conditions
Interventions
Medical Device : Procedure & Intervention
1. Assess the presence and degree of cerebral vasospasm of the target vessel
through cerebral angiography before the interventional procedure.
2. Solitai
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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. 3. Individuals who voluntarily signed the informed consent form to participate in this study.
Exclusion criteria
Exclusion criteria: 1. Pre-existing intracranial stenosis = 50% 2. Patients whose condition makes further evaluation and procedures difficult - Exclude if Hunt and Hess grade is 4 or higher. 3. Difficult vascular access - 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. 5. Cerebral vasospasm caused by vasculitis or dissection. 6. Hypersensitivity to medications to be used (contrast agents, vasodilators..). 7. Pregnancy or breastfeeding. 8. History of connective tissue disease or blood coagulation disorders. 9. Patients with untreated areas of subarachnoid hemorrhage. 10. Patients with symptoms due to other causes (e.g., hydrocephalus, infection, etc.). 11. Irreversible cerebral infarction in the entire vascular territory where vasospasm occurred. 12. Known allergy to medical device materials (Nitinol, Platinum, Iridium). 13. Bleeding or coagulation disorders (Platelet count 1.7). 14. In case of rapid worsening of cerebral hemorrhage symptoms , cerebral edema, surgery, or other urgent treatment required. 15. Subject with uncontrolled blood pressure (SBP x2 upper normal limit ). 17. Subject with renal dysfunction (eGFR < 60 mL/min/1.73?). 18. Subject with clinically significant cardiac complications such as arrhythmia, heart failure, or myocardial infarction. 19. Subject with brain edema or elevated intracranial pressure. 20. Known current or past use of illicit drugs or alcohol abuse. 21. Requiring the administration of medications contraindicated with nimodipine. 22. Subject with systemic complications such as infection, fever, inflammation, edema, hypersensitivity, foreign body reaction, toxicity, or shock. 23. Subject with visual impairment or ocular complications. 24. Any other cases where the investigator determines that participation in the clinical trial is not possible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the safety (adverse events) of the interventional procedure. During the stent-angioplasty(using Solitaore-X) IA nimodipine was also infused.); Intervention Success Rate (Recovery of more than 50% of the pre-procedure vessel diameter, measured at 24 hours and 72 hours after the intervention.);Need for Additional Treatment.;Symptom Improvement (NIHSS): Improvement in NIHSS at 3 months after Cerebral Vasospasm Onset.;Clinical Improvement (mRS): Improvement in mRS at 3 months post-CVO.;Degree of Cerebral Vasospasm (Degree of cerebral vasospasm as observed in CT cerebral angiography at 24 hours and 72 hours after the intervention.) | — |
Secondary
| Measure | Time frame |
|---|---|
| modified Rankin Scale & NIHSS Scale at discharge and 3 months after discharge | — |
Countries
Korea, Republic of
Contacts
Public ContactKeun Young Park
Yonsei University
Outcome results
None listed