Registry on NeVa VS for CerebraL VAsospasm ManagemenT in Post SAH PatiEnts

Purpose

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)

Eligibility

Eligible Ages
Over 22 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Study Type
Observational [Patient Registry]
Observational Model
Case-Only
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Treatment Group
  • Device: NEVA VS
    cerebral artery dilation device

Recruiting Locations

Providence St. Joseph Medical Center
Burbank, California 91505
Contact:
Sandra Narayanan, MD
818-869-7067
sandra.narayanan@providence.org

John Muir Health
Walnut Creek, California 94589
Contact:
Benjamin Yim, MD
925-692-5603
Benjamin.Yim@johnmuirhealth.com

Yale
New Haven, Connecticut 06520
Contact:
Charles Matouk, MD
203-737-2096
charles.matouk@yale.edu

Baptist Health South Florida
Miami, Florida 33143
Contact:
Italo Linfante, MD
305-596-3876
Italol@baptisthealth.net

Wellstar Health System
Marietta, Georgia 30062
Contact:
Juan Carlos Martinez Guittierez, MD
770-664-9600
martinez.juancarlos@gmail.com

Endeavor Health
Evanston, Illinois 60201
Contact:
Shakeel Chowdhry, MD
847-570-1440
schowdhry@northshore.org

Univ Iowa
Iowa City, Iowa 52242
Contact:
Edgar Samaniego, MD
319-353-6629
esamaniego@uiowa.edu

Univ Kentucky
Lexington, Kentucky 40506
Contact:
Mais Al-Kawaz, MD
859-323-5661
mais.alkawaz@uky.edu

MaineHealth
Portland, Maine 04102
Contact:
Robert Ecker, MD
207-885-0011
robert.ecker@mainehealth.org

Mayo Clinic- Rochester
Rochester, Minnesota 55905
Contact:
Guiseppe Lanzino, MD
507-284-8167
lanzino.giuseppe@mayo.edu

Allegheny Health Network
Pittsburgh, Pennsylvania 15222
Contact:
Andrew Ku, MD
412-359-3946
andrew.ku@ahn.org

Geisinger
Wilkes-Barre, Pennsylvania 18711
Contact:
Philipp Hendrix, MD
570-214-2432
cmschirmer@geisinger.edu

Valley Baptist Medical Center- Harlingen
Harlingen, Texas 78550
Contact:
Ameer Hassan, MD
956-389-1124
sofia.lopez@tenethealth.com

University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Robert Regenhardt, MD
832-310-3811
robert.regenhardt@uth.tmc.edu

Uni. of Utah
Salt Lake City, Utah 84112
Contact:
Karol Budohoski, MD
801-581-6908
karol.budohoski@hsc.utah.edu

West Virginia University
Morgantown, West Virginia 26505
Contact:
Sohyun Boo, MD
304-293-7012
sboo@hsc.wvu.edu

More Details

NCT ID
NCT06893588
Status
Recruiting
Sponsor
Vesalio

Study Contact

Sharon Shachar, Graduate
2486976616
sshachar@vesalio.com