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

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

More Details

Status
Recruiting
Sponsor
Vesalio

Study Contact

Sharon Shachar, Graduate
2486976616
sshachar@vesalio.com