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

Sponsor
Vesalio (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03926988
Collaborator
(none)
400
Enrollment
1
Location
1
Arm
42
Anticipated Duration (Months)
9.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A prospective, open label, 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.

Condition or Disease Intervention/Treatment Phase
  • Device: NeVa Stent Retriever
 N/A

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 400 subjects at up 20 sites will participate in the study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Apr 1, 2019
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Intervention

NeVa Stent Retriever

Device: NeVa Stent Retriever
mechanical neurothrombectomy

Outcome Measures

Primary Outcome Measures

  1. Recanalization rate of occluded target vessel [post-procedure day 0]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Inclusion Criteria: Only subjects already treated with the NeVa devices can be considered for enrollment.

  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. Age ≥18

  2. NIHSS score ≥ 6

  3. Pre-stroke mRS score of ≤ 1

  4. 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.

  5. Thrombectomy procedure can be initiated within 24 hours from symptom onset (defined as time last known well [TLKW])

  6. Imaging Inclusion Criteria:

7.1. Non-Contrast CT Selection (if CT Perfusion or MRI not utilized): ASPECTS 6-10 if treatment started 0-6 hours from TLKW ASPECTS 8-10 if treatment started 6-24 hours from TLKW

7.2. CT Perfusion core ≤50 cc

7.3. MRI DWI core ≤50 cc

  1. Subject or legal representative is able and willing to give informed consent within 48 hours after the intervention.
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)

  11. Inability to deploy NeVA device for at least one pass for any other reason

  12. Life expectancy less than 6 months

  13. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vall d'Hebron Barcelona Spain

Sponsors and Collaborators

  • Vesalio

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vesalio
ClinicalTrials.gov Identifier:
NCT03926988
Other Study ID Numbers:
  • VS-005 / D
First Posted:
Apr 25, 2019
Last Update Posted:
Mar 9, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Stroke
Ischemic Stroke

Study Results

No Results Posted as of Mar 9, 2022