Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | NeVa VS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeVa VS | Device | mechanical dilatation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RIA Neurovascular Clinic | Englewood | Colorado | 80113 | United States | ||
| Baptist Health System |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | NeVa VS NeVa VS: mechanical dilatation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | NeVa VS NeVa VS: mechanical dilatation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Procedural Success | defined as 50% or greater vessel caliber on DSA compared to baseline, as determined by the core laboratory | The VITAL study data were analyzed using descriptive statistics due to the small sample size (N=30). | Posted | Count of Units | Vessels Treated | within 30 minutes of completion of procedure | Vessels Treated | Vessels Treated |
|
|
30 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm - NeVa VS Intervention | NeVa VS Intervention | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraprocedural thrombotic event | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraprocedural thrombotic event | Vascular disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sigi Caron, President and CEO at BioMDg | BioMDg, CRO for VITAL Study | (831) 346-6970 | sigi@biomdg.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 23, 2020 | Dec 7, 2022 | Prot_SAP_ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D020301 | Vasospasm, Intracranial |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Jacksonville |
| Florida |
| 32207 |
| United States |
| Wellstar Health System | Marietta | Georgia | 30062 | United States |
| University of Buffalo | Buffalo | New York | 14204 | United States |
| North Shore University Hospital - Northwell | Manhasset | New York | 11030 | United States |
| Mount Sinai Health System | New York | New York | 10029 | United States |
| SUNY Stony Brook University | Stony Brook | New York | 11794 | United States |
| Fort Sanders Regional Med Center | Knoxville | Tennessee | 37916 | United States |
| TTUHSC El Paso | El Paso | Texas | 79905 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Vessels Treated |
|
|
| 30 |
| 17 |
| 30 |
| 25 |
| 30 |
| Cerebral infarct | Vascular disorders | Systematic Assessment |
|
| Cerebral infarct secondary to vasospasm | Vascular disorders | Systematic Assessment |
|
| Pseudoaneurysm of the contralateral femoral artery | Vascular disorders | Systematic Assessment |
|
| Ruptured vessel due to balloon angioplasty | Vascular disorders | Systematic Assessment |
|
| Worsening cardiomyopathy | Cardiac disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Cerebral infarct secondary to vasospasm | Vascular disorders | Systematic Assessment |
|
| Aspiration pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Bacteremia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Cerebral hemorrhage secondary to right ventriculostomy catheter removal | Vascular disorders | Systematic Assessment |
|
| Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pseudoaneurysm of the brachial artery | Vascular disorders | Systematic Assessment |
|
| Recurrent SAH | Vascular disorders | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | Systematic Assessment |
|
| Worsening ascites | Gastrointestinal disorders | Systematic Assessment |
|
| Worsening hydrocephalus | Nervous system disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
|
| Anemia post-24 hours | Blood and lymphatic system disorders | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
|
| Cerebral salt wasting syndrome | Nervous system disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Cerebral infarct secondary to vasospasm | Vascular disorders | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
The data resulting from this study is the proprietary information of the Sponsor. None of the data resulting from this study will be allowed to be presented or published in any form, by the investigator or any other person, without the prior written approval of the Sponsor.
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |