NeVa ONE Registry Study
Primary Purpose
Acute Ischemic Stroke
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
NeVa Stent Retriever
Sponsored by
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring Thrombus, stroke
Eligibility Criteria
Inclusion Criteria:
Only subjects already treated with the NeVa thrombectomy devices can be considered for enrollment.
- Age ≥18
- NIHSS score ≥ 6
- Pre-stroke mRS score ≤ 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 24 hours from symptom onset (defined as time last known well [TLKW])
Imaging Inclusion Criteria:
The patient should have confirmed LVO and salvageable penumbra. Any automated software for determine the volume of viable tissue is acceptable. patient selection should follow the following guidelines:
- ASPECTS 6-10 if treatment started 0-6 hours from TLKW
- ASPECTS 8-10 if treatment started 6-24 hours from TLKW
- Ischemic core ≤ 50 cc
- Subject or legal representative is able and willing to give informed consent within 72 hours after the intervention (may use independent physician consent in this timeframe and gain subject or legal representative consent later than 72 hours).
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)
- 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.
Sites / Locations
- Hospital Espanol de MendozaRecruiting
- Niguarda HospitalRecruiting
- Cleveland Clinic Abu DhabiRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intervention
Arm Description
NeVa Stent Retriever
Outcomes
Primary Outcome Measures
First Pass Success Rate
The primary study endpoint is the first pass success rate with the NeVa device defined as eTICI score ≥ 2B & eTICI ≥2C
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04562194
Brief Title
NeVa ONE Registry Study
Official Title
NEVA ONE One-Pass Reperfusion With the NeVa Stent-Retriever EMEA Registry
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vesalio
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
A prospective, open label study designed to assess the safety, performance and efficacy of thrombus removal in subjects presenting with acute ischemic stroke with the NeVa stent retrievers.
Detailed Description
This is a prospective, open label, multi-center registry designed to assess the safety, performance and efficacy of the NeVa stent retriever in the treatment of large vessel occlusion strokes. Up to 600 subjects will be enrolled at up 30 sites.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
Thrombus, stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Other
Arm Description
NeVa Stent Retriever
Intervention Type
Device
Intervention Name(s)
NeVa Stent Retriever
Intervention Description
mechanical neurothrombectomy
Primary Outcome Measure Information:
Title
First Pass Success Rate
Description
The primary study endpoint is the first pass success rate with the NeVa device defined as eTICI score ≥ 2B & eTICI ≥2C
Time Frame
post-procedure day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Only subjects already treated with the NeVa thrombectomy devices can be considered for enrollment.
Age ≥18
NIHSS score ≥ 6
Pre-stroke mRS score ≤ 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 24 hours from symptom onset (defined as time last known well [TLKW])
Imaging Inclusion Criteria:
The patient should have confirmed LVO and salvageable penumbra. Any automated software for determine the volume of viable tissue is acceptable. patient selection should follow the following guidelines:
ASPECTS 6-10 if treatment started 0-6 hours from TLKW
ASPECTS 8-10 if treatment started 6-24 hours from TLKW
Ischemic core ≤ 50 cc
Subject or legal representative is able and willing to give informed consent within 72 hours after the intervention (may use independent physician consent in this timeframe and gain subject or legal representative consent later than 72 hours).
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)
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antoine Cuijpers
Phone
+31 6 51 55 99 37
Email
acuijpers@vesalio.com
Facility Information:
Facility Name
Hospital Espanol de Mendoza
City
Mendoza
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando Petra, MD
Facility Name
Niguarda Hospital
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edoardo Boccardi
Phone
+39 3516775140
Facility Name
Cleveland Clinic Abu Dhabi
City
Abu Dhabi
Country
United Arab Emirates
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Shelby, MD
Phone
+971 2 659 0200
12. IPD Sharing Statement
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NeVa ONE Registry Study
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