Intracranial VasospasmNCT06615882
Mechanical Intracranial Artery DilAtation Using Stent-retriever for Cerebral Vasospasm
A study testing stent-angioplasty & nimodipine infusion (During the stent (Solitaire-X) -angioplasty, IA nimodipine was also infused) in people with Intracranial Vasospasm, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Vasospasm
- What is being tested?
- stent-angioplasty & nimodipine infusion (During the stent (Solitaire-X) -angioplasty, IA nimodipine was also infused)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2024to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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
Read the detailed description
Prospective exploratory study, single arm (off label), single center study I. Procedure \& Intervention
- Assess the presence and degree of cerebral vasospasm of the target vessel through cerebral angiography before the procedure.
- Solitaire-X stent types are selected
- During the stent-angioplasty, IA nimodipine was also infused.
- Retrieve Solitaire-X after maintaining deployment for 3 minutes.
- Additional procedures are determined through immediate post-procedure and 15-minute delayed cerebral angiography.
- Conditions
- Intracranial Vasospasm
- Being tested
- stent-angioplasty & nimodipine infusion (During the stent (Solitaire-X) -angioplasty, IA nimodipine was also infused)
- Medical subject headings
- Vasospasm, Intracranial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stent-angioplasty & nimodipine infusion (During the stent (Solitaire-X) -angioplasty, IA nimodipine was also infused)Device
- Procedure \& Intervention
- Assess the presence and degree of cerebral vasospasm of the target vessel through cerebral angiography before the procedure.
- Solitaire-X stent types are selected
- During the stent-angioplasty, IA nimodipine was also infused.
- Retrieve Solitaire-X after maintaining deployment for 3 minutes.
- Additional procedures are determined through immediate post-procedure and 15-minute delayed cerebral angiography.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | During the stent (Solitaire-X) -angioplasty, IA nimodipine was also infused Receives: Device: stent-angioplasty & nimodipine infusion (During the stent (Solitaire-X) -angioplasty, IA nimodipine was also infused) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the safety (adverse events) of the interventional procedure.
Measured: at 24 hours and 72 hours after the intervention at 3 months after Cerebral Vasospasm Onset.
Secondary outcomes (5)
Intervention Success Rate
Recovery of more than 50% of the pre-procedure vessel diameter, measured at 24 hours and 72 hours after the intervention.
Measured: 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
Measured: On the 1 day of the subject's intervention
Symptom Improvement (NIHSS)
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
Measured: Improvement in NIHSS at 3 months after Cerebral Vasospasm Onset.
Clinical Improvement (mRS)
mRS: Modified Rankin Score 0: None
- No significant disability despite symptoms: able to carry out all usual duties and activities
- Slight disability: unable to carry out all previous activities, but able to look after own affairs without assistance
- Moderate disability: requiring some help, but able to walk without assistance
- Moderately severe disability: unable to walk without assistance, unable to attend to needs without assistance
- Severe disability: bed-ridden, incontinent, and requiring constant nursing care and attention
- Dead
Measured: at 24 hours and 72 hours after the intervention at 3 months after Cerebral Vasospasm Onset.
Degree of Cerebral Vasospasm
- 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%)
Measured: observed in CT cerebral angiography at 24 hours and 72 hours after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study startSep 2024 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial VasospasmStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615882
- Sponsor's protocol ID
- 1-2024-0013
- Status last verified
- Sep 2024
- First submitted
- 8 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06615882
- Acronym / sponsor ID
- 1-2024-0013
- Conditions
- Intracranial Vasospasm
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Assess the presence and degree of cerebral vasospasm of the target vessel through cerebral angiography before the procedure.
- Solitaire-X stent types are selected
- During the stent-angioplasty, IA nimodipine was also infused.
- Retrieve Solitaire-X after maintaining deployment for 3 minutes.
- Additional procedures are determined through immediate post-procedure and 15-minute delayed cerebral angiography.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: stent-angioplasty & nimodipine infusion (During the stent (Solitaire-X) -angioplasty, IA nimodipine was also infused)During the stent (Solitaire-X) -angioplasty, IA nimodipine was also infused |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
- 3. Individuals who voluntarily signed the informed consent form to participate in this study.
Key exclusion criteria (11 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Experimental |
Primary outcome
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.
5 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Intracranial Vasospasm
Not yet recruiting
Endovascular Therapy for Cerebral Vasospasm After Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Cerebral Vasospasm After Subarachnoid Hemorrhage
Not yet recruiting
Noninvasive CA Monitoring Validation and Autonomic Modulation in Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Delayed Cerebral Ischemia
Not yet recruitingPhase 4
Lumbar Drain With Intrathecal Nicardipine in Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Hemorrhage
Recruiting
The Effect of Transcutaneous Vagal Nerve Stimulation (tVNS) on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid Hemorrhage
Aneurysmal Subarachnoid Hemorrhage, Vasospasm, Cerebral
RecruitingObservational study
Nitric Oxide Consumption as a Predictor of Vasospasm in Subarachnoid Hemorrhage
Aneurysmal Subarachnoid Hemorrhage, Cerebral Vasospasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stent-angioplasty & nimodipine infusion (During the stent (Solitaire-X) -angioplasty, IA nimodipine was also infused) in people with Intracranial Vasospasm, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.