Search / Trial NCT06615882

Mechanical Intracranial Artery DilAtation Using Stent-retriever for Cerebral Vasospasm

Launched by YONSEI UNIVERSITY · Sep 26, 2024

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Trial Information

Current as of December 31, 2024

Not yet recruiting

Keywords

ClinConnect Summary

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.

Gender

ALL

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.

About Yonsei University

Yonsei University, a prestigious institution located in South Korea, is renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, Yonsei University leverages its extensive expertise and innovative approaches in various fields of medicine to conduct rigorous clinical trials aimed at improving patient outcomes and advancing healthcare solutions. The university's robust infrastructure, multidisciplinary collaboration, and adherence to ethical standards ensure the integrity and reliability of its research initiatives, making it a key player in the global clinical research landscape.

Locations

Seoul, , Korea, Republic Of

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0