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Vesalio NeVa VS for Symptomatic Cerebral Vasospasm Following aSAH (The VITAL Study)
NA trial testing NeVa VS in Cerebral Vasospasm in 30 participants. Completed in 31 May 2021.
| Lead sponsor | Vesalio |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 19 December 2018 |
| Primary completion | 31 May 2021 |
| Estimated completion | 31 May 2021 |
| Sites | 10 locations across United States |
Vesalio — full company profile →
18 and older, any sex, with Cerebral Vasospasm. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
defined as 50% or greater vessel caliber on DSA compared to baseline, as determined by the core laboratory
| Group | Value | 95% CI |
|---|---|---|
| Single Arm - NeVa VS Intervention | 64 |
Time frame: 30 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Single Arm - NeVa VS Inter… |
|---|---|---|
| Anemia | Blood and lymphatic system disorders | — |
| Cerebral infarct secondary to vasospasm | Vascular disorders | — |
| Intraprocedural thrombotic event | Vascular disorders | — |
| Cerebral infarct | Vascular disorders | — |
| Cerebral infarct secondary to vasospasm | Vascular disorders | — |
| Pseudoaneurysm of the contralateral femoral artery | Vascular disorders | — |
| Ruptured vessel due to balloon angioplasty | Vascular disorders | — |
| Worsening cardiomyopathy | Cardiac disorders | — |
| Aspiration pneumonia | Respiratory, thoracic and mediastinal disorders | — |
| Atrial fibrillation | Cardiac disorders | — |
| Bacteremia | Blood and lymphatic system disorders | — |
| Cerebral hemorrhage secondary to right ventriculostomy catheter removal | Vascular disorders | — |
| Fall | Musculoskeletal and connective tissue disorders | — |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | — |
| Pseudoaneurysm of the brachial artery | Vascular disorders | — |
| Recurrent SAH | Vascular disorders | — |
| Sepsis | Infections and infestations | — |
| Ventricular tachycardia | Cardiac disorders | — |
| Worsening ascites | Gastrointestinal disorders | — |
| Worsening hydrocephalus | Nervous system disorders | — |
| Reaction | System | Single Arm - NeVa VS Inter… |
|---|---|---|
| Urinary tract infection | Renal and urinary disorders | — |
| Anemia post-24 hours | Blood and lymphatic system disorders | — |
| Deep vein thrombosis | Vascular disorders | — |
| Cerebral salt wasting syndrome | Nervous system disorders | — |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Intraprocedural thrombotic event | Vascular disorders | — |
| Cerebral infarct secondary to vasospasm | Vascular disorders | — |
| Tachycardia | Cardiac disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
Most-reported serious reactions: Anemia, Cerebral infarct secondary to vasospasm, Intraprocedural thrombotic event, Cerebral infarct, Cerebral infarct secondary to vasospasm, Pseudoaneurysm of the contralateral femoral artery, Ruptured vessel due to balloon angioplasty, Worsening cardiomyopathy.
Data from ClinicalTrials.gov NCT03611790 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03611790.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing