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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03927001
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : August 17, 2020
Sponsor:
Information provided by (Responsible Party):
Vesalio

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.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Device: NeVa Stent Retrievers Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Intervention
NeVa Stent Retrievers
Device: NeVa Stent Retrievers
mechanical neurothrombectomy




Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 is able and willing to give informed consent prior to 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 [≤ 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927001


Contacts
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Contact: Kathleen Calderon 615-206-7788 kcalderon@vesalio.com

Locations
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Spain
Vall d'Hebron Recruiting
Barcelona, Spain
Contact: Marc Ribo, MD    932746000 ext 6326    marccriboj@hotmail.com   
Sponsors and Collaborators
Vesalio
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Responsible Party: Vesalio
ClinicalTrials.gov Identifier: NCT03927001    
Other Study ID Numbers: VS-006 / E
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: August 17, 2020
Last Verified: August 2020

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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
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases