Status:
UNKNOWN
The Vesalio NeVa Stent Retriever Study for Treatment of Large Vessel Occlusion Strokes: CLEAR Study
Lead Sponsor:
Vesalio
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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 ret...
Detailed Description
This is a prospective, open label, multi-center, single-arm trial designed to assess the safety, performance and efficacy of the NeVa stent retriever in the treatment of large vessel occlusion strokes...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
April 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04514562
Start Date
April 3 2021
End Date
August 1 2023
Last Update
January 17 2023
Active Locations (7)
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1
Vascular Neurology of Southern California
Thousand Oaks, California, United States, 91360
2
Baptist Health Research Institute
Jacksonville, Florida, United States, 32207
3
WellStar System Inc
Marietta, Georgia, United States, 30060
4
Community Hospital
Munster, Indiana, United States, 46321