Mechanical Intracranial Artery DilAtation Using Stent-retriever for Cerebral Vasospasm

Launched by YONSEI UNIVERSITY · Sep 26, 2024

Keywords

ClinConnect Summary

This clinical trial, called "Mechanical Intracranial Artery DilAtation Using Stent-retriever for Cerebral Vasospasm," is studying a medical device named Solitaire-X, which is typically used to help restore blood flow in the brain during certain types of strokes. In this trial, researchers want to see if Solitaire-X can also help patients who are experiencing a condition called intracranial vasospasm, which is when blood vessels in the brain tighten and restrict blood flow. Participants will be patients aged 19 and older who have been diagnosed with severe vasospasm that hasn't improved with standard treatments.

To be eligible for this study, participants must have certain types of vasospasm, including those caused by a brain bleed or other serious conditions. They should also be able to give their permission to join the study. However, some people, such as those with certain heart or kidney issues, or those who are pregnant, won't be able to participate. If someone joins the trial, they can expect to be closely monitored for safety and effectiveness as they receive treatment with the Solitaire-X device. This research is important because it could lead to new ways to help patients with this challenging condition.

Gender

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Eligibility 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:
• • 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 \< 20,000 or INR \> 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 \< 100 mmHg). 16. Subject with liver dysfunction (AST/ALT \> 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.