Vesalio NeVa VS for Symptomatic Cerebral Vasospasm Following aSAH (The VITAL Study)

NCT03611790 | Completed Results DMC FDA Device

• 1 other identifier: VS-002 / D
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 10

Brief Summary

The objective of the study is to assess the safety and probable benefit of the Neva VS device in patients presenting with symptomatic cerebral vasospasm despite maximal medical management following aSAH.

Conditions

Cerebral Vasospasm

Outcome Measures

Primary Outcomes (1)

• Procedural Success

  defined as 50% or greater vessel caliber on DSA compared to baseline, as determined by the core laboratory

  within 30 minutes of completion of procedure

Study Arms (1)

Intervention

EXPERIMENTAL

NeVa VS

Device: NeVa VS

Interventions

NeVa VS DEVICE

mechanical dilatation

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Subarachnoid hemorrhage secondary to ruptured aneurysm.
• Ruptured aneurysm secured with surgical clipping or endovascular intervention.
• Digital subtraction angiography (DSA) or CT angiography at the time of aSAH clinical presentation or aSAH intervention with well-visualized intra-cerebral vessels is available for review.
• Vasospasm in one or more of the following: the internal carotid artery (ICA), basilar, middle cerebral artery (MCA), anterior cerebral artery (ACA), or posterior cerebral artery (PCA) territory on transcranial Doppler (TCD), and/or CT angiography, and/or clinical signs of symptomatic vasospasm (change in level of consciousness, focal neurological deficit) confirmed by \> 50% narrowing in these territories on DSA.
• Vasospasm despite maximized medical management defined as oral Nimodipine (unless contraindicated), systemic hypertension with SBP greater than 130 mmHg and euvolemia.
• Target vessel pre-vasospasm diameter ≥ 2 mm and ≤ 4.0 mm.
• Subject or legal representative is able and willing to give informed consent.

You may not qualify if:

• Symptoms attributable to other causes (e.g., hydrocephalus, metabolic, infection).
• Hunt and Hess Grade of 5
• Large infarct on CT scan defined as ASPECTS 0-5.
• Intracranial hemorrhage not caused by aneurysm rupture.
• History of bleeding disorders.
• Baseline platelets \< 30,000.
• International normalized ratio (INR) \> 1.7.
• Any known contraindications to mechanical dilation of vasospastic vessels including but not limited to:
• Excessive vessel tortuosity that prevents the placement of the device
• Evidence of rapidly improving neurological signs of stroke
• Large territory completed cerebral infarction, edema with mass effect and intra-parenchymal hemorrhage in vascular territory to be treated, or
• any other vascular anatomic variants or anomalies
• Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia with prescribed anti-cholinesterase inhibitor (e.g. Aricept).
• History of severe allergy to contrast medium.
• Known allergy to NeVa materials (nitinol, stainless steel).

Sponsors & Collaborators

• Vesalio: lead

Study Sites (10)

RIA Neurovascular Clinic

Englewood, Colorado, 80113, United States

Location

Baptist Health System

Jacksonville, Florida, 32207, United States

Location

Wellstar Health System

Marietta, Georgia, 30062, United States

Location

University of Buffalo

Buffalo, New York, 14204, United States

Location

North Shore University Hospital - Northwell

Manhasset, New York, 11030, United States

Location

Mount Sinai Health System

New York, New York, 10029, United States

Location

SUNY Stony Brook University

Stony Brook, New York, 11794, United States

Location

Fort Sanders Regional Med Center

Knoxville, Tennessee, 37916, United States

Location

TTUHSC El Paso

El Paso, Texas, 79905, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Vasospasm, Intracranial

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Sigi Caron, President and CEO at BioMDg
• Organization: BioMDg, CRO for VITAL Study

sigi@biomdg.com

(831) 346-6970

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: August 2, 2018
• Study Start: December 19, 2018
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: January 3, 2023
• Results First Posted: January 3, 2023

Record last verified: 2022-12

Locations

US (10)