Cerebral VasospasmDILATENCT06893588
Registry on NeVa VS for CerebraL VAsospasm ManagemenT in Post SAH PatiEnts
An observational study of Cerebral Vasospasm and Aneurysmal Subarachnoid Hemorrhage (aSAH), run by Vesalio at 16 sites in United States.
Trial summary
A multi-center, observational registry study intended to assess the HDE-approved NeVa VS cerebral artery dilation device in patients with symptomatic cerebral vasospasm caused by aneurysmal subarachnoid hemorrhage (aSAH) Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cerebral Vasospasm, Aneurysmal Subarachnoid Hemorrhage (aSAH)
- What is being tested?
- NEVA VS
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 16 sitesUnited States
- Study dates
- 14 Apr 2025to 15 Mar 2027
- How long will I take part?
- 30 Days
- Phase
- Observational
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: subjects with cerebral vasospasm
Who may be able to join
- Age ≥22
- Symptomatic cerebral vasospasm secondary to aneurysmal subarachnoid hemorrhage (aSAH) in the internal carotid artery (ICA), middle cerebral artery (MCA), anterior cerebral artery (ACA), posterior cerebral artery (PCA), or basilar artery (BA)
- Vessel dilation procedure was performed with the NeVa VS
- Subject or legal representative is able and willing to give informed consent within 3 days (72 hours) post-index procedure
Who cannot join
- None
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
United States16 sites, 16 recruiting
- Recruiting
Providence St. Joseph Medical Center
Burbank, California, 91505
Sandra Narayanan, MD, 818-869-7067, sandra.narayanan@providence.org
- Recruiting
Endeavor Health
Evanston, Illinois, 60201
Shakeel Chowdhry, MD, 847-570-1440, schowdhry@northshore.org
- Recruiting
Valley Baptist Medical Center- Harlingen
Harlingen, Texas, 78550
Ameer Hassan, MD, 956-389-1124, sofia.lopez@tenethealth.com
- Recruiting
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Robert Regenhardt, MD, 832-310-3811, robert.regenhardt@uth.tmc.edu
- Recruiting
Univ Iowa
Iowa City, Iowa, 52242
Edgar Samaniego, MD, 319-353-6629, esamaniego@uiowa.edu
- Recruiting
Univ Kentucky
Lexington, Kentucky, 40506
Mais Al-Kawaz, MD, 859-323-5661, mais.alkawaz@uky.edu
- Recruiting
Wellstar Health System
Marietta, Georgia, 30062
Juan Carlos Martinez Guittierez, MD, 770-664-9600, martinez.juancarlos@gmail.com
- Recruiting
Baptist Health South Florida
Miami, Florida, 33143
Italo Linfante, MD, 305-596-3876, Italol@baptisthealth.net
- Recruiting
West Virginia University
Morgantown, West Virginia, 26505
Sohyun Boo, MD, 304-293-7012, sboo@hsc.wvu.edu
- Recruiting
Yale
New Haven, Connecticut, 06520
Charles Matouk, MD, 203-737-2096, charles.matouk@yale.edu
- Recruiting
Allegheny Health Network
Pittsburgh, Pennsylvania, 15222
Andrew Ku, MD, 412-359-3946, andrew.ku@ahn.org
- Recruiting
MaineHealth
Portland, Maine, 04102
Robert Ecker, MD, 207-885-0011, robert.ecker@mainehealth.org
- Recruiting
Mayo Clinic- Rochester
Rochester, Minnesota, 55905
Guiseppe Lanzino, MD, 507-284-8167, lanzino.giuseppe@mayo.edu
- Recruiting
Uni. of Utah
Salt Lake City, Utah, 84112
Karol Budohoski, MD, 801-581-6908, karol.budohoski@hsc.utah.edu
- Recruiting
John Muir Health
Walnut Creek, California, 94589
Benjamin Yim, MD, 925-692-5603, Benjamin.Yim@johnmuirhealth.com
- Recruiting
Geisinger
Wilkes-Barre, Pennsylvania, 18711
Philipp Hendrix, MD, 570-214-2432, cmschirmer@geisinger.edu
About this study
Official title: Prospective, Open-Label, Multi-Center ProceDural Data CollectIon Case Registry on NeVa VS for CerebraL VAsospasm ManagemenT in Post SAH PatiEnts (The DILATE Registry)
A multi-center, observational registry study intended to assess the HDE-approved NeVa VS cerebral artery dilation device in patients with symptomatic cerebral vasospasm caused by aneurysmal subarachnoid hemorrhage (aSAH)
- Being tested
- NEVA VS
- Keywords
- vasospasm
- Medical subject headings
- Vasospasm, Intracranial, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEVA VSDevice
cerebral artery dilation device
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Not described Receives: Device: NEVA VS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in target vessel diameter following NeVa VS use
Measured: Up to 1 hour post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start14 Apr 2025
- Primary completion14 Feb 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Vesalio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893588
- Sponsor's protocol ID
- VS-011
- Acronym
- DILATE
- Status last verified
- May 2026
- First submitted
- 3 Feb 2025
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open-Label, Multi-Center ProceDural Data CollectIon Case Registry on NeVa VS for CerebraL VAsospasm ManagemenT in Post SAH PatiEnts (The DILATE Registry)
- ClinicalTrials.gov ID
- NCT06893588
- Acronym / sponsor ID
- DILATE / VS-011
- Keywords
- vasospasm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- VesalioIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 14 Feb 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 25 Mar 2025 (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.
A multi-center, observational registry study intended to assess the HDE-approved NeVa VS cerebral artery dilation device in patients with symptomatic cerebral vasospasm caused by aneurysmal subarachnoid hemorrhage (aSAH)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | – | Device: NEVA VS |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- subjects with cerebral vasospasm
Key inclusion criteria (4 listed)
- Age ≥22
- Symptomatic cerebral vasospasm secondary to aneurysmal subarachnoid hemorrhage (aSAH) in the internal carotid artery (ICA), middle cerebral artery (MCA), anterior cerebral artery (ACA), posterior cerebral artery (PCA), or basilar artery (BA)
- Vessel dilation procedure was performed with the NeVa VS
- Subject or legal representative is able and willing to give informed consent within 3 days (72 hours) post-index procedure
Key exclusion criteria (1 listed)
- None
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 VScerebral artery dilation device | Device | Treatment Group |
Primary outcome
Improvement in target vessel diameter following NeVa VS use
Time frame: Up to 1 hour post procedure
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 May 2026.
- Individual participant dataSharing planned: No
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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.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Vasospasm and Aneurysmal Subarachnoid Hemorrhage (aSAH), run by Vesalio at 16 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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
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?
Contact Sharon Shachar, Graduate (2486976616, sshachar@vesalio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in target vessel diameter following NeVa VS use (time frame: Up to 1 hour post 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 27 May 2026.