- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03927001
The Vesalio NeVa Stent Retriever Study for Treatment of Large Vessel Occlusion Strokes
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Barcelona, Spain
- Vall d'Hebron
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke, and subject belongs to one of the following subgroups:
1.1. Subject has failed IV t-PA therapy
1.2. Subject is contraindicated for IV t-PA administration
1.3. IV-tPA given within 3 hours of symptom onset
- Age ≥18 and less than equal to 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:
7.1. Non-Contrast CT Selection (if CT Perfusion or MRI not utilized): ASPECTS 6-10 , or
7.2. CT Perfusion core ≤50 cc, or
7.3. MRI DWI core ≤50 cc
- Subject or (legal) representative or independent physician (if approved by site's regional ethics committee, see site's informed consent form) is able and willing to give informed consent prior to the interventions.
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, significant cardiac arrhythmia, 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 [≤ 3cm])
- 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.
- Active malignancy
- Stenosis or occlusion in a proximal vessel requiring treatment or preventing access to the thrombus.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Intervention
NeVa Stent Retrievers
|
mechanical neurothrombectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recanalization rate of the occluded target vessel
Time Frame: post-procedure day 0
|
Recanalization rate of the occluded target vessel (defined by an eTICI score ≥ 2b) following three or less passes using the NeVa device(s).
|
post-procedure day 0
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VS-006 / G
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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