Recruiting

NeVa

Sponsor:

Vesalio

Code:

NCT06893588

Conditions

Cerebral Vasospasm

Aneurysmal Subarachnoid Hemorrhage (aSAH)

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

NEVA VS

Study Details

Brief 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)

Conditions

Cerebral Vasospasm

Aneurysmal Subarachnoid Hemorrhage (aSAH)

Study ID

NCT06893588

Start date

Apr 14, 2025

Status verified date

May, 2026

Completion date

Mar 15, 2027

Anticipated

Primary completion date

Feb 14, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Treatment Group

Interventions

NEVA VS

cerebral artery dilation device

Primary outcome measure

  • Improvement in target vessel diameter following NeVa VS use [ Time Frame: Up to 1 hour post procedure ]

Central Contacts and Locations

Central contacts

Sharon Shachar, Graduate

2486976616sshachar@vesalio.com

Locations

Providence St. Joseph Medical Center

Recruiting

Burbank, California, United States, 91505

Contacts

Sandra Narayanan, MD

818-869-7067sandra.narayanan@providence.org

John Muir Health

Recruiting

Walnut Creek, California, United States, 94589

Contacts

Benjamin Yim, MD

925-692-5603Benjamin.Yim@johnmuirhealth.com

Yale

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Charles Matouk, MD

203-737-2096charles.matouk@yale.edu

Baptist Health South Florida

Recruiting

Miami, Florida, United States, 33143

Contacts

Italo Linfante, MD

305-596-3876Italol@baptisthealth.net

Wellstar Health System

Recruiting

Marietta, Georgia, United States, 30062

Contacts

Juan Carlos Martinez Guittierez, MD

770-664-9600martinez.juancarlos@gmail.com

Endeavor Health

Recruiting

Evanston, Illinois, United States, 60201

Contacts

Shakeel Chowdhry, MD

847-570-1440schowdhry@northshore.org

Univ Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Edgar Samaniego, MD

319-353-6629esamaniego@uiowa.edu

Univ Kentucky

Recruiting

Lexington, Kentucky, United States, 40506

Contacts

Mais Al-Kawaz, MD

859-323-5661mais.alkawaz@uky.edu

MaineHealth

Recruiting

Portland, Maine, United States, 04102

Contacts

Robert Ecker, MD

207-885-0011robert.ecker@mainehealth.org

Mayo Clinic- Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Guiseppe Lanzino, MD

507-284-8167lanzino.giuseppe@mayo.edu

Allegheny Health Network

Recruiting

Pittsburgh, Pennsylvania, United States, 15222

Contacts

Andrew Ku, MD

412-359-3946andrew.ku@ahn.org

Geisinger

Recruiting

Wilkes-Barre, Pennsylvania, United States, 18711

Contacts

Philipp Hendrix, MD

570-214-2432cmschirmer@geisinger.edu

Valley Baptist Medical Center- Harlingen

Recruiting

Harlingen, Texas, United States, 78550

Contacts

Ameer Hassan, MD

956-389-1124sofia.lopez@tenethealth.com

University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Robert Regenhardt, MD

832-310-3811robert.regenhardt@uth.tmc.edu

Uni. of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Karol Budohoski, MD

801-581-6908karol.budohoski@hsc.utah.edu

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26505

Contacts

Sohyun Boo, MD

304-293-7012sboo@hsc.wvu.edu

More Information

Sponsor

Vesalio

Last update posted

May 27, 2026

Last verified

May, 2026

Keywords

  • vasospasm

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Vesalio on 2026-05-27.