Cerebral VasospasmNCT03611790
Vesalio NeVa VS for Symptomatic Cerebral Vasospasm Following aSAH (The VITAL Study)
A study testing NeVa VS in people with Cerebral Vasospasm, run by Vesalio at 10 sites in United States.
Trial summary
The objective of the study is to assess the safety and probable benefit of the Neva VS device in patients presenting with symptomatic cerebral vasospasm despite maximal medical management following aSAH. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Vasospasm
- What is being tested?
- NeVa VS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 10 sitesUnited States
- Study dates
- 19 Dec 2018to 31 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age ≥ 18 years.
- Subarachnoid hemorrhage secondary to ruptured aneurysm.
- Ruptured aneurysm secured with surgical clipping or endovascular intervention.
- Digital subtraction angiography (DSA) or CT angiography at the time of aSAH clinical presentation or aSAH intervention with well-visualized intra-cerebral vessels is available for review.
- Vasospasm in one or more of the following: the internal carotid artery (ICA), basilar, middle cerebral artery (MCA), anterior cerebral artery (ACA), or posterior cerebral artery (PCA) territory on transcranial Doppler (TCD), and/or CT angiography, and/or clinical signs of symptomatic vasospasm (change in level of consciousness, focal neurological deficit) confirmed by > 50% narrowing in these territories on DSA.
- Vasospasm despite maximized medical management defined as oral Nimodipine (unless contraindicated), systemic hypertension with SBP greater than 130 mmHg and euvolemia.
- Target vessel pre-vasospasm diameter ≥ 2 mm and ≤ 4.0 mm.
- Subject or legal representative is able and willing to give informed consent.
Who cannot join
- The presence of an unsecured ruptured aneurysm. Note unsecured unruptured aneurysms remote to the site of treated aSAH are not an exclusionary.
- Symptoms attributable to other causes (e.g., hydrocephalus, metabolic, infection).
- Hunt and Hess Grade of 5
- Large infarct on CT scan defined as ASPECTS 0-5.
- Intracranial hemorrhage not caused by aneurysm rupture.
- History of bleeding disorders.
Show all 21Show fewer
- Baseline platelets < 30,000.
- International normalized ratio (INR) > 1.7.
- Any known contraindications to mechanical dilation of vasospastic vessels including but not limited to:
- Excessive vessel tortuosity that prevents the placement of the device
- Evidence of rapidly improving neurological signs of stroke
- Large territory completed cerebral infarction, edema with mass effect and intra-parenchymal hemorrhage in vascular territory to be treated, or
- any other vascular anatomic variants or anomalies
- Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia with prescribed anti-cholinesterase inhibitor (e.g. Aricept).
- History of severe allergy to contrast medium.
- Known allergy to NeVa materials (nitinol, stainless steel).
- Suspected or confirmed septic embolus, or bacterial endocarditis.
- Septic shock or central nervous system (CNS) infection confirmed via cerebrospinal fluid (CSF) sampling.
- Known current or recent use of illicit drugs or alcohol abuse.
- Females who are pregnant or breastfeeding.
- Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure is performed.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Buffalo
Buffalo, New York, 14204
TTUHSC El Paso
El Paso, Texas, 79905
RIA Neurovascular Clinic
Englewood, Colorado, 80113
Houston Methodist Hospital
Houston, Texas, 77030
Baptist Health System
Jacksonville, Florida, 32207
Fort Sanders Regional Med Center
Knoxville, Tennessee, 37916
North Shore University Hospital - Northwell
Manhasset, New York, 11030
Wellstar Health System
Marietta, Georgia, 30062
Mount Sinai Health System
New York, New York, 10029
SUNY Stony Brook University
Stony Brook, New York, 11794
About this study
Official title: The Vesalio Neva VS for the Treatment of Symptomatic Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage (aSAH) (The VITAL Study)
The objective of the study is to assess the safety and probable benefit of the Neva VS device in patients presenting with symptomatic cerebral vasospasm despite maximal medical management following aSAH.
Read the detailed description
This is a prospective, open label, single-arm study. Up to 30 eligible subjects at up to 15 sites will participate in the study. Subjects will be followed up for 30 days post-intervention.
- Conditions
- Cerebral Vasospasm
- Being tested
- NeVa VS
- Medical subject headings
- Vasospasm, Intracranial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeVa VSDevice
mechanical dilatation
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | NeVa VS Receives: Device: NeVa VS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Success
defined as 50% or greater vessel caliber on DSA compared to baseline, as determined by the core laboratory
Measured: within 30 minutes of completion of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start19 Dec 2018
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cerebral VasospasmStudies of the same condition, open and under way.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vesalio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611790
- Sponsor's protocol ID
- VS-002 / D
- Status last verified
- Dec 2022
- First submitted
- 18 Jul 2018
- Last updated
- 3 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Vesalio Neva VS for the Treatment of Symptomatic Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage (aSAH) (The VITAL Study)
- ClinicalTrials.gov ID
- NCT03611790
- Acronym / sponsor ID
- VS-002 / D
- Conditions
- Cerebral Vasospasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- VesalioIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 2 Aug 2018 (actual)
- Results
- Posted 3 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to assess the safety and probable benefit of the Neva VS device in patients presenting with symptomatic cerebral vasospasm despite maximal medical management following aSAH.
Detailed description
This is a prospective, open label, single-arm study. Up to 30 eligible subjects at up to 15 sites will participate in the study. Subjects will be followed up for 30 days post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: NeVa VSNeVa VS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years.
- Subarachnoid hemorrhage secondary to ruptured aneurysm.
- Ruptured aneurysm secured with surgical clipping or endovascular intervention.
- Digital subtraction angiography (DSA) or CT angiography at the time of aSAH clinical presentation or aSAH intervention with well-visualized intra-cerebral vessels is available for review.
- Vasospasm in one or more of the following: the internal carotid artery (ICA), basilar, middle cerebral artery (MCA), anterior cerebral artery (ACA), or posterior cerebral artery (PCA) territory on transcranial Doppler (TCD), and/or CT angiography, and/or clinical signs of symptomatic vasospasm (change in level of consciousness, focal neurological deficit) confirmed by > 50% narrowing in these territories on DSA.
Key exclusion criteria (21 listed)
- The presence of an unsecured ruptured aneurysm. Note unsecured unruptured aneurysms remote to the site of treated aSAH are not an exclusionary.
- Symptoms attributable to other causes (e.g., hydrocephalus, metabolic, infection).
- Hunt and Hess Grade of 5
- Large infarct on CT scan defined as ASPECTS 0-5.
- Intracranial hemorrhage not caused by aneurysm rupture.
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 |
|---|---|---|
| NeVa VSmechanical dilatation | Device | Intervention |
Primary outcome
Procedural Success
Time frame: within 30 minutes of completion of procedure
defined as 50% or greater vessel caliber on DSA compared to baseline, as determined by the core laboratory
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeVa VS in people with Cerebral Vasospasm, run by Vesalio at 10 sites in United States.
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 8 inclusion and 21 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: finished, as of the sponsor's last update on 3 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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?
Yes. Results are posted in the registry (first posted 3 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Procedural Success (time frame: within 30 minutes of completion of procedure). 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 3 Jan 2023; AzTrials last refreshed its copy on 7 Nov 2026.