Vesalio NeVa VS for Symptomatic Cerebral Vasospasm Following aSAH (The VITAL Study) (NCT03611790) | Clinical Trial Compass
CompletedNot Applicable
Vesalio NeVa VS for Symptomatic Cerebral Vasospasm Following aSAH (The VITAL Study)
United States30 participantsStarted 2018-12-19
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ble…
What they're measuring
1
Procedural Success
Timeframe: within 30 minutes of completion of procedure