Cerebral Vasospasm Registry Using NeVa VS After Aneurysmal Subarachnoid Hemorrhage
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)
Run by Vesalio · NCT06893588 · Data updated 2026-11-12
This registry tests the NeVa VS device in adults with symptomatic cerebral vasospasm after an aneurysmal subarachnoid hemorrhage to see how it performs in real-world centers.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 22 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Vesalio Industry-sponsored |
| Locations | 16 sites (Burbank, California and 15 other locations) |
| Status | Recruiting |
| Started | April 14, 2025 |
| Main results expected | February 14, 2027 |
| Study ends | March 15, 2027 |
| Registry record updated | May 27, 2026 |
| Trial ID | NCT06893588 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 22 and older with symptomatic cerebral vasospasm from aSAH who have undergone a vessel-dilation procedure with NeVa VS.
✕Probably not a fit
Patients with cerebral vasospasm who do not receive NeVa VS or who are outside the eligibility window may not benefit from information gathered in this registry.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multi-center observational registry collects data on patients treated with the NeVa VS cerebral artery dilation device for symptomatic cerebral vasospasm following aneurysmal subarachnoid hemorrhage. It includes adults 22 and older and follows patients through the post-procedure period to document outcomes and device performance. Data are gathered from participating centers to understand safety, feasibility, and patterns of use in routine clinical practice. The study design is non-randomized and relies on standard-of-care treatment decisions made by treating physicians. No control group is planned, and findings will be descriptive and hypothesis-generating for future research.
Why it matters
Potential benefit: If successful, the registry could clarify how NeVa VS performs in real-world patients with vasospasm after aSAH and inform best-use practices.
How similar studies have gone: Observational registries in device use for cerebral vasospasm have provided useful real-world insights, though this specific NeVa VS registry is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥22 2. 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) 3. Vessel dilation procedure was performed with the NeVa VS 4. Subject or legal representative is able and willing to give informed consent within 3 days (72 hours) post-index procedure Exclusion Criteria: * None
Where it's running
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Providence St. Joseph Medical Center
Burbank, California, United States Recruiting -
John Muir Health
Walnut Creek, California, United States Recruiting -
Yale
New Haven, Connecticut, United States Recruiting -
Baptist Health South Florida
Miami, Florida, United States Recruiting -
Wellstar Health System
Marietta, Georgia, United States Recruiting -
Endeavor Health
Evanston, Illinois, United States Recruiting
Show 10 more locations
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Univ Iowa
Iowa City, Iowa, United States Recruiting -
Univ Kentucky
Lexington, Kentucky, United States Recruiting -
MaineHealth
Portland, Maine, United States Recruiting -
Mayo Clinic- Rochester
Rochester, Minnesota, United States Recruiting -
Allegheny Health Network
Pittsburgh, Pennsylvania, United States Recruiting -
Geisinger
Wilkes-Barre, Pennsylvania, United States Recruiting -
Valley Baptist Medical Center- Harlingen
Harlingen, Texas, United States Recruiting -
University of Texas Health Science Center at Houston
Houston, Texas, United States Recruiting -
Uni. of Utah
Salt Lake City, Utah, United States Recruiting -
West Virginia University
Morgantown, West Virginia, United States Recruiting
Study contacts
- Study coordinator: Sharon Shachar, Graduate
- Email: sshachar@vesalio.com
- Phone: 2486976616
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Nitric Oxide Use to Predict Vasospasm in Aneurysmal Subarachnoid Hemorrhage
This study tests whether nitric oxide consumption in CSF can predict cerebral vasospasm in patients with aneurysmal SAH.
-
Scalp block for headache after aneurysmal subarachnoid hemorrhage in ICU patients
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Tracking delayed ischemic neurological deficits in people with aneurysmal subarachnoid hemorrhage — real-world data
This project will collect real-world monitoring and treatment information to see how often delayed ischemic neurological deficits (DIND) happen and what diagnostic and treatment approaches people with aneurysmal subarachnoid hemorrhage receive.
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Intranasal sphenopalatine ganglion block for headache after a ruptured brain aneurysm
This will test whether spraying a numbing medicine into the back of the nose can reduce severe headache in adults recovering from a ruptured brain aneurysm.
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Understanding cerebral vasospasm in traumatic brain injury with subarachnoid hemorrhage
This study is testing how common and serious blood vessel narrowing in the brain is for adults with moderate to severe traumatic brain injuries and bleeding, to see if better scans can help improve their care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.