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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03611790
Other study ID # VS-002 / D
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 19, 2018
Est. completion date May 31, 2021

Study information

Verified date December 2022
Source Vesalio
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This is a prospective, open label, single-arm study. Up to 30 eligible subjects at up to 15 sites will participate in the study. Subjects will be followed up for 30 days post-intervention.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date May 31, 2021
Est. primary completion date May 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria - 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. Exclusion Criteria - The presence of an unsecured ruptured aneurysm. Note unsecured unruptured aneurysms remote to the site of treated aSAH are not an exclusionary. - 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). - Suspected or confirmed septic embolus, or bacterial endocarditis. - Septic shock or central nervous system (CNS) infection confirmed via cerebrospinal fluid (CSF) sampling. - Known current or recent use of illicit drugs or alcohol abuse. - Females who are pregnant or breastfeeding. - Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure is performed.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
NeVa VS
mechanical dilatation

Locations

Country Name City State
United States University of Buffalo Buffalo New York
United States TTUHSC El Paso El Paso Texas
United States RIA Neurovascular Clinic Englewood Colorado
United States Houston Methodist Hospital Houston Texas
United States Baptist Health System Jacksonville Florida
United States Fort Sanders Regional Med Center Knoxville Tennessee
United States North Shore University Hospital - Northwell Manhasset New York
United States Wellstar Health System Marietta Georgia
United States Mount Sinai Health System New York New York
United States SUNY Stony Brook University Stony Brook New York

Sponsors (1)

Lead Sponsor Collaborator
Vesalio

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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