Background Cerebral vasospasm (CV) after aneurysmal subarachnoid hemorrhage (aSAH) is linked to worse neurological outcomes. The NeVa VS is a novel cerebral dilation device based on predicate stent retrievers. We report the results of the Vesalio NeVa VS for the Treatment of Symptomatic Cerebral Vasospasm following aSAH (VITAL) Study.
Methods This was a single-arm prospective multicenter trial to assess the safety and probable benefit of the NeVa VS device to treat CV. Patients were screened and treated if they had CV >50% on non-invasive imaging confirmed by cerebral angiography. The vessel diameters were measured before and after treatment by an independent core laboratory. The primary endpoint was ≥50% vessel diameter immediately after treatment with the NeVa VS device.
Results Thirty patients with a mean age of 52±11 years and mean Hunt–Hess grade of 3.1±0.9 were enrolled. A total of 74 vessels were treated with an average of 1.3 deployments per vessel (95 deployments total). The mean pre-treatment narrowing of the target vessel (n=74) was 65.6% with reduction of the narrowing to 29.4% after treatment. The primary endpoint was achieved in 64 of 74 vessels (86.5%). In three of 95 total deployments (3.2%), thrombus at the site of deployment was observed during the procedure without apparent neurological sequelae.
Conclusions The NeVa VS device appears to be a safe treatment to regain vessel diameter in severely narrowed intracranial arteries secondary to CV associated with aSAH. This treatment offers a new tool that allows for controlled vessel expansion to treat CV.
Data availability statement
Data are available upon reasonable request.
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Contributors RG and AM: Drafted the manuscript and performed analysis and interpretation of the data. DL: Data collection, interpretation of imaging and critical revision of the manuscript. KW, DFi, HHW, DFr, AS, RDL, RH and LE: Critical revision of the manuscript.
Funding This study was funded by Vesalio (N/A).
Competing interests RG: Principal Investigator (PI) for the TIGER study (Rapid Medical), PI for the ASSIST Registry (Stryker Neurovascular), PI for the RECCLAIM II Study (Zoll), CLEAR Study (Vesalio), Clinical Events Committee (CEC) for the MIND Trial (Penumbra), Steering Committee member for MEMBRANE study Cerenovous; Shareholder for Rapid Medical and Vesalio. KW: Consultant: Cerenovus, Medtronic, Microvention, Penumbra, Stryker. DFi: JNIS Editorial Board – Deputy Editor, Medtronic – Consulting, Proctoring, Cerenovous – Consulting, Microvention – Consulting, Proctoring, Research Support, Penumbra – Research Support, Stryker – Consulting, Research Support, Balt USA – Consulting, Research Support, Siemens – Research Support, MENTICE-Vascular Simulations – Stock Holder, Consultant, Neurogami – Stock Holder, Consultant, Marblehead – Consultant, Stock Holder, RAPID.AI – Consultant, RAPID Medical – Consultant, Qapel Medical – Honorarium, Consultant, Arsenal Medical – Consultant, Phenox Medical – Consultant. DL: Consultant as imaging core lab to Cerenovus, Genentech, Medtronic, Stryker, Rapid Medical and Vesalio. DFr: Consultant/Speakers Bureau: Penumbra, Stryker; Research support: Cerenovus, Medtronic, Microvention, Penumbra, Stryker; Stock ownership: Penumbra. IL: Consultant for Medtronic, Stryker, Cerenovus. AS: Consultant for Amnis Therapeutics, Apellis Pharmaceuticals, Boston Scientific, Canon Medical Systems USA, Cerebrotech Medical Systems, Cerenovous, Corindus, Endostream Medical, Imperative Care, Integra Lifesciences Corp, IRRAS, Medtronic, Microvention, Minnetronix Neuro, Northwest University-DSMB for HEAT trial, Penumbra, Perflow Medical, Q’Apel Medical, Rapid Medical, Rebound Therapeutics Corp, Serenity Medical, Silk Road Medical, StimMed, Stryker, Three Rivers Medical, VasSol, Viz.ai, W L Gore Associates; National PI/Steering Committee for Cerenovous NAPA Trial and ARISE II Trial, Medtronic SWIFT PRIME and SWIFT DIRECT Trials, Microvention FRED Trial and CONFIDENCE Study, MUSC POSITIVE Trial, Penumbra 3D Separator Trial, COMPASS Trial, INVEST Trial; Financial interests in Adona Medical, Amnis Therapeutics, Bend IT Technologies, BlinkTBI, Boston Scientific Corp (for purchase of Claret Medical), Buffalo Technology Partners, Cardinal Consultants, Cerebrotech Medical Systems, Cognition Medical, Endostream Medical, Imperative Care, Instylla, International Medical Distribution Partners, IRRAS, LaunchNY Seed Fund Management, NeuroRadial Technologies, Neurovascular Diagnostics, Perflow Medical, Q’Apel, Radical Catheter Technologies, Rebound Therapeutics Corp (Purchased 2019 by Integra Lifesciences Corp), Rist Neurovascular, Sense Diagnostics, Serenity Medical, Silk Road Medical, Spinnaker Medical, StimMed, Synchron, Three Rivers Medical, Truvic Medical, Vastrax, VICIS, Viseon, Viz.ai; Research grants as co-investigator NIH/NINDS 1RO1NS091075 Virtual intervention of aneurysms and Co-Principal Investigator NIH-NINDS R21 NS109575-01 Optimizing approaches to endovascular therapy of acute ischemic stroke. RDL: Consultant for Stryker, Cerenovus, Penumbra; Equity: Q’Apel, Synchron, Endostream. RH: Consultant for Rapid Medical, Medtronic, Stryker, Cerenovous, Balt, Phenox, Elum, MIVI; Shareholder for ThromX, Cerebrotech, Endostream, RIST, REIST, Serenity, BendIT. LE: Consulting: Medtronic, Microvention, Stryker, Scientia, VizAI, Cerenovus; Research Support: Siemens.
Provenance and peer review Not commissioned; externally peer reviewed.
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