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

Primary Purpose

Acute Ischemic Stroke

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
NeVa Stent Retrievers
Sponsored by
Vesalio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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

  2. Age ≥18 and less than equal to 85
  3. NIHSS score ≥ 8 and ≤ 25
  4. Prestroke mRS score of ≤ 1
  5. 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.
  6. 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
  7. 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

  8. 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:

  1. 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).
  2. Cardiopulmonary resuscitation, significant cardiac arrhythmia, evidence of ongoing myocardial infarction, concern for pre-treatment pulmonary aspiration.
  3. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
  4. Cerebral vasculitis
  5. History of severe allergy to contrast medium.
  6. Known allergy to NeVa materials (nitinol, stainless steel);
  7. Suspicion of aortic dissection, septic embolus, or bacterial endocarditis
  8. Systemic infection
  9. Significant mass effect with midline shift
  10. Evidence of intracranial tumor (except small meningioma [≤ 3cm])
  11. Any CT or MRI evidence of acute hemorrhage products on presentation
  12. Inability to deploy NeVA device for at least one pass for any other reason
  13. Life expectancy less than 6 months
  14. 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.
  15. Active malignancy
  16. Stenosis or occlusion in a proximal vessel requiring treatment or preventing access to the thrombus.

Sites / Locations

  • Vall d'Hebron

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intervention

Arm Description

NeVa Stent Retrievers

Outcomes

Primary Outcome Measures

Recanalization rate of the occluded target vessel
Recanalization rate of the occluded target vessel (defined by an eTICI score ≥ 2b) following three or less passes using the NeVa device(s).

Secondary Outcome Measures

Full Information

First Posted
April 18, 2019
Last Updated
January 13, 2023
Sponsor
Vesalio
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1. Study Identification

Unique Protocol Identification Number
NCT03927001
Brief Title
The Vesalio NeVa Stent Retriever Study for Treatment of Large Vessel Occlusion Strokes
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 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
Data Monitoring Committee
Yes

5. Study Description

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 retrievers.
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. Up to 150 subjects at up 20 sites will participate in the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic 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
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Other
Arm Description
NeVa Stent Retrievers
Intervention Type
Device
Intervention Name(s)
NeVa Stent Retrievers
Intervention Description
mechanical neurothrombectomy
Primary Outcome Measure Information:
Title
Recanalization rate of the occluded target vessel
Description
Recanalization rate of the occluded target vessel (defined by an eTICI score ≥ 2b) following three or less passes using the NeVa device(s).
Time Frame
post-procedure day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Vall d'Hebron
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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