The Vesalio NeVa Stent Retriever Study for Treatment of Large Vessel Occlusion Strokes: CLEAR Study

Status unconfirmed · Not applicable

Conditions studied: Acute Ischemic Stroke

In brief

A prospective, open label, single-arm 90-day study designed to assess the safety, performance and efficacy of thrombus removal in subjects presenting with acute ischemic stroke with the NeVa stent retrievers.

Key facts

Study ID

NCT04514562

Run by

Vesalio

People needed

120

Starts

2021-04-03

Expected to finish

2023-08-01

Last updated by the study team

2023-01-17

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke, and subject belongs to one of the following subgroups:
• 1. Subject has failed IV t-PA therapy
• 2. Subject is contraindicated for IV t-PA administration
• 3. 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:
• 1. Non-Contrast CT Selection (if CT Perfusion or MRI not utilized): ASPECTS 6-10 , or
• 2. CT Perfusion core ≤50 cc, or
• 3. MRI DWI core ≤50 cc
• Subject or legal representative is able and willing to give informed consent prior to the intervention

You may not qualify if…

• 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.

Where it is running

• Vascular Neurology of Southern California — Thousand Oaks, California, United States
• Baptist Health Research Institute — Jacksonville, Florida, United States
• WellStar System Inc — Marietta, Georgia, United States
• Community Hospital — Munster, Indiana, United States
• University of Maryland Medical Center Dept of Diagnostic Radiology & Nuclear Med. — Baltimore, Maryland, United States
• Fort Sanders Regional — Knoxville, Tennessee, United States
• Texas Tech University Health — El Paso, Texas, United States

Full record on ClinicalTrials.gov

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