Mechanical Intracranial Artery DilAtation Using Stent-retriever for Cerebral Vasospasm

September 26, 2024 updated by: Yonsei University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
During the stent (Solitaire-X) -angioplasty, IA nimodipine was also infused
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
at 24 hours and 72 hours after the intervention at 3 months after Cerebral Vasospasm Onset.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention Success Rate
Time Frame: at 24 hours and 72 hours after the intervention at 3 months after Cerebral Vasospasm Onset.
Recovery of more than 50% of the pre-procedure vessel diameter, measured at 24 hours and 72 hours after the intervention.
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
On the 1 day of the subject's intervention
Symptom Improvement (NIHSS)
Time Frame: Improvement in NIHSS at 3 months after Cerebral Vasospasm Onset.
NIHSS: National Institutes of Health Stroke Scale Score 0: no stroke Score 1-4: minor stroke Score 5-15: moderate stroke Score 15-20: moderate to severe stroke Score 21-42: severe stroke
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.

mRS: Modified Rankin Score 0: None

  1. No significant disability despite symptoms: able to carry out all usual duties and activities
  2. Slight disability: unable to carry out all previous activities, but able to look after own affairs without assistance
  3. Moderate disability: requiring some help, but able to walk without assistance
  4. Moderately severe disability: unable to walk without assistance, unable to attend to needs without assistance
  5. Severe disability: bed-ridden, incontinent, and requiring constant nursing care and attention
  6. Dead
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.
  • Visual classification: Cerebral vasospasm grades (CVSG). Grade 0 All intracranial vessels show a physiological shape Grade 1 Vasospasm affects the A2, A1, and M2 segments Grade 2 Vasospasm expands to the M1 and terminal segment of the internal carotid artery Grade 3 Severe reduction in the intradural internal carotid artery with filiform A1 and M1 segments, which sometimes appears like a ghost (ghost sign)

  • Degree of diameter reduction

    • None (0-10%),
    • Mild (11-49%),
    • Moderate (50-69%),
    • Severe (70-99%)
observed in CT cerebral angiography at 24 hours and 72 hours after the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

September 8, 2024

First Submitted That Met QC Criteria

September 26, 2024

First Posted (Actual)

September 27, 2024

Study Record Updates

Last Update Posted (Actual)

September 27, 2024

Last Update Submitted That Met QC Criteria

September 26, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-2024-0013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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