Clinical trial NCT06615882: Mechanical Intracranial Artery DilAtation Using Stent-retriever for Cerebral Vasospasm
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intracranial Vasospasm
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Assess the safety (adverse events) of the interventional procedure.
timeFrame: at 24 hours and 72 hours after the intervention at 3 months after Cerebral Vasospasm Onset.
Secondary outcomes:
measure: Intervention Success Rate
timeFrame: at 24 hours and 72 hours after the intervention at 3 months after Cerebral Vasospasm Onset.
measure: Whether additional treatment is required after intervention (; in relation to cerebral vasospasm) questionnaire
timeFrame: On the 1 day of the subject's intervention
measure: Symptom Improvement (NIHSS)
timeFrame: Improvement in NIHSS at 3 months after Cerebral Vasospasm Onset.
measure: Clinical Improvement (mRS)
timeFrame: at 24 hours and 72 hours after the intervention at 3 months after Cerebral Vasospasm Onset.
measure: Degree of Cerebral Vasospasm
timeFrame: observed in CT cerebral angiography at 24 hours and 72 hours after the intervention.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei university college of medicine
Study officials:
References: