A Study to Evaluate The Vesalio NeVa Stent Retriever To Treatment of Large Vessel Occlusion Strokes
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 21-001164
NCT ID: NCT04514562
Sponsor Protocol Number: VS-001
About this study
The purpose of this study is to assess the safety, performance and effectiveness of thrombus removal in subjects presenting with acute ischemic stroke with the NeVa stent retrievers.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke, and subject belongs to one of the following subgroups:
- Subject has failed IV t-PA therapy;
- Subject is contraindicated for IV t-PA administration;
- IV-tPA given within 3 hours of symptom onset.
- Age ≥ 18 and ≤ 85.
- NIHSS score ≥ 8 and ≤ 25.
- Prestroke mRS score of ≤ 1.
- Intracranial arterial occlusion of the distal intracranial carotid artery or middle cerebral artery (M1/M2), anterior cerebral artery (ACA), posterior cerebral artery (PCA), basilar artery, or vertebral artery demonstrated with DSA.
- Thrombectomy procedure can be initiated within 8 hours from symptom onset (defined as time last known well [TLKW]) and at least one NeVa pass occurring within 8 hours.
- Imaging Inclusion Criteria:
- Non-Contrast CT Selection (if CT Perfusion or MRI not utilized): ASPECTS 6-10 ; or
- CT Perfusion core ≤ 50 cc; or
- MRI DWI core ≤ 50 cc.
- Subject or legal representative is able and willing to give informed consent prior to the intervention
Exclusion Criteria:
- Pre-existing medical neurological or psychiatric disease that would confound the neurological or functional evaluations; e.g., dementia with prescribed anti-cholinesterase inhibitor (e.g., Aricept).
- Cardiopulmonary resuscitation, cardiac arrhythmia resulting in hemodynamic instability (hypotension) that is not easily medically correctable, evidence of ongoing myocardial infarction, concern for pre-treatment pulmonary aspiration.
- Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
- Cerebral vasculitis.
- History of severe allergy to contrast medium.
- Known allergy to NeVa materials (nitinol, stainless steel).
- Suspicion of aortic dissection, septic embolus, or bacterial endocarditis.
- Systemic infection.
- Significant mass effect with midline shift.
- Evidence of intracranial tumor (except small meningioma [≤ 3 cm]).
- Any CT or MRI evidence of acute hemorrhage products on presentation.
- Inability to deploy NeVa device for at least one pass for any other reason.
- Life expectancy less than 6 months.
- Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed.
- Females you are pregnant or breastfeeding.
- Active malignancy.
- Stenosis or occlusion in a proximal vessel requiring treatment or preventing access to the thrombus.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Waleed Brinjikji, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available