Clinical trial Recruiting at 16 sites Observational Ages 22 and up

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 typeObservational
Ages22 Years and up
SexAll
Enrollment200 (estimated)
SponsorVesalio
Industry-sponsored
Locations16 sites (Burbank, California and 15 other locations)
StatusRecruiting
StartedApril 14, 2025
Main results expectedFebruary 14, 2027
Study endsMarch 15, 2027
Registry record updatedMay 27, 2026
Trial IDNCT06893588 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.