Trial Outcomes & Findings for Vesalio NeVa VS for Symptomatic Cerebral Vasospasm Following aSAH (The VITAL Study) (NCT NCT03611790)
NCT ID: NCT03611790
Last Updated: 2023-01-03
Results Overview
defined as 50% or greater vessel caliber on DSA compared to baseline, as determined by the core laboratory
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
within 30 minutes of completion of procedure
Results posted on
2023-01-03
Participant Flow
Participant milestones
| Measure |
Intervention
NeVa VS
NeVa VS: mechanical dilatation
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vesalio NeVa VS for Symptomatic Cerebral Vasospasm Following aSAH (The VITAL Study)
Baseline characteristics by cohort
| Measure |
Intervention
n=30 Participants
NeVa VS
NeVa VS: mechanical dilatation
|
|---|---|
|
Age, Continuous
|
51.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 30 minutes of completion of procedurePopulation: The VITAL study data were analyzed using descriptive statistics due to the small sample size (N=30).
defined as 50% or greater vessel caliber on DSA compared to baseline, as determined by the core laboratory
Outcome measures
| Measure |
Single Arm - NeVa VS Intervention
n=74 Vessels Treated
NeVa VS Intervention
|
|---|---|
|
Procedural Success
|
64 Vessels Treated
|
Adverse Events
Single Arm - NeVa VS Intervention
Serious events: 17 serious events
Other events: 25 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Single Arm - NeVa VS Intervention
n=30 participants at risk
NeVa VS Intervention
|
|---|---|
|
Vascular disorders
Intraprocedural thrombotic event
|
6.7%
2/30 • Number of events 2 • 30 days
|
|
Vascular disorders
Cerebral infarct
|
3.3%
1/30 • Number of events 1 • 30 days
|
|
Vascular disorders
Cerebral infarct secondary to vasospasm
|
10.0%
3/30 • Number of events 3 • 30 days
|
|
Vascular disorders
Pseudoaneurysm of the contralateral femoral artery
|
3.3%
1/30 • Number of events 1 • 30 days
|
|
Vascular disorders
Ruptured vessel due to balloon angioplasty
|
3.3%
1/30 • Number of events 1 • 30 days
|
|
Cardiac disorders
Worsening cardiomyopathy
|
3.3%
1/30 • Number of events 1 • 30 days
|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
3/30 • Number of events 3 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonia
|
3.3%
1/30 • Number of events 1 • 30 days
|
|
Cardiac disorders
Atrial fibrillation
|
3.3%
1/30 • Number of events 1 • 30 days
|
|
Blood and lymphatic system disorders
Bacteremia
|
3.3%
1/30 • Number of events 1 • 30 days
|
|
Vascular disorders
Cerebral hemorrhage secondary to right ventriculostomy catheter removal
|
3.3%
1/30 • Number of events 1 • 30 days
|
|
Musculoskeletal and connective tissue disorders
Fall
|
3.3%
1/30 • Number of events 1 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.3%
1/30 • Number of events 1 • 30 days
|
|
Vascular disorders
Pseudoaneurysm of the brachial artery
|
3.3%
1/30 • Number of events 1 • 30 days
|
|
Vascular disorders
Recurrent SAH
|
3.3%
1/30 • Number of events 1 • 30 days
|
|
Infections and infestations
Sepsis
|
3.3%
1/30 • Number of events 1 • 30 days
|
|
Cardiac disorders
Ventricular tachycardia
|
3.3%
1/30 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Worsening ascites
|
3.3%
1/30 • Number of events 1 • 30 days
|
|
Nervous system disorders
Worsening hydrocephalus
|
3.3%
1/30 • Number of events 1 • 30 days
|
Other adverse events
| Measure |
Single Arm - NeVa VS Intervention
n=30 participants at risk
NeVa VS Intervention
|
|---|---|
|
Vascular disorders
Intraprocedural thrombotic event
|
10.0%
3/30 • Number of events 3 • 30 days
|
|
Blood and lymphatic system disorders
Anemia
|
6.7%
2/30 • Number of events 2 • 30 days
|
|
Renal and urinary disorders
Urinary tract infection
|
26.7%
8/30 • Number of events 8 • 30 days
|
|
Blood and lymphatic system disorders
Anemia post-24 hours
|
20.0%
6/30 • Number of events 6 • 30 days
|
|
Vascular disorders
Deep vein thrombosis
|
16.7%
5/30 • Number of events 6 • 30 days
|
|
Nervous system disorders
Cerebral salt wasting syndrome
|
16.7%
5/30 • Number of events 5 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
16.7%
5/30 • Number of events 5 • 30 days
|
|
Gastrointestinal disorders
Diarrhea
|
13.3%
4/30 • Number of events 4 • 30 days
|
|
Vascular disorders
Cerebral infarct secondary to vasospasm
|
10.0%
3/30 • Number of events 3 • 30 days
|
|
Cardiac disorders
Tachycardia
|
10.0%
3/30 • Number of events 3 • 30 days
|
Additional Information
Sigi Caron, President and CEO at BioMDg
BioMDg, CRO for VITAL Study
Phone: (831) 346-6970
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER