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

NCT ID: NCT06893588

Last Updated: 2025-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-14

Study Completion Date

2027-03-15

Brief Summary

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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)

Detailed Description

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Conditions

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Cerebral Vasospasm Aneurysmal Subarachnoid Hemorrhage (aSAH)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment Group

NEVA VS

Intervention Type DEVICE

cerebral artery dilation device

Interventions

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NEVA VS

cerebral artery dilation device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vesalio

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Sharon Shachar, Graduate

Role: CONTACT

2486976616

Other Identifiers

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VS-011

Identifier Type: -

Identifier Source: org_study_id

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