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

Overview

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.

Interventions

• 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.

Primary outcome measures

• 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.]

Secondary outcome measures (5)

• Intervention Success Rate [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) [Time frame: Improvement in NIHSS at 3 months after Cerebral Vasospasm Onset.]
• Clinical Improvement (mRS) [Time frame: at 24 hours and 72 hours after the intervention at 3 months after Cerebral Vasospasm Onset.]
• Degree of Cerebral Vasospasm [Time frame: observed in CT cerebral angiography at 24 hours and 72 hours after the intervention.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

South Korea · 1 center

• Yonsei university college of medicine — Seoul

Identifiers

NCT: NCT06615882 · 1-2024-0013

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗