Cerebral Vasospasm
Conditions
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.
Detailed 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.
Interventions
DEVICENeVa VS
mechanical dilatation
Sponsors
Vesalio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Success | within 30 minutes of completion of procedure | defined as 50% or greater vessel caliber on DSA compared to baseline, as determined by the core laboratory |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention NeVa VS
NeVa VS: mechanical dilatation | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Continuous | 51.8 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 30 |
| other Total, other adverse events | 25 / 30 |
| serious Total, serious adverse events | 17 / 30 |
Outcome results
Primary
Procedural Success
defined as 50% or greater vessel caliber on DSA compared to baseline, as determined by the core laboratory
Time frame: within 30 minutes of completion of procedure
Population: The VITAL study data were analyzed using descriptive statistics due to the small sample size (N=30).
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Single Arm - NeVa VS Intervention | Procedural Success | 64 Vessels Treated |