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出境医 / 临床实验 / The Vesalio NeVa Stent Retriever Study for Treatment of Large Vessel Occlusion Strokes

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

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.

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.
Study Design
Layout table for study information
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
Arms and Interventions
Arm Intervention/treatment
Intervention
NeVa Stent Retrievers
 Device: NeVa Stent Retrievers
mechanical neurothrombectomy
Outcome Measures
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).


Eligibility Criteria
Layout table for eligibility information
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.
Contacts and Locations

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

Locations
Layout table for location information
Spain
Vall d'Hebron Recruiting
Barcelona, Spain
Contact: Marc Ribo, MD    932746000 ext 6326    marccriboj@hotmail.com   
Sponsors and Collaborators
Vesalio
Tracking Information
First Submitted Date  ICMJE April 18, 2019
First Posted Date  ICMJE April 25, 2019
Last Update Posted Date August 17, 2020
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2019) 		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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Vesalio NeVa Stent Retriever Study for Treatment of Large Vessel Occlusion Strokes
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Ischemic Stroke
Intervention  ICMJE Device: NeVa Stent Retrievers
mechanical neurothrombectomy
Study Arms  ICMJE Intervention
NeVa Stent Retrievers
Intervention: Device: NeVa Stent Retrievers
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 22, 2019) 		150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kathleen Calderon 615-206-7788 kcalderon@vesalio.com
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03927001
Other Study ID Numbers  ICMJE VS-006 / E
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vesalio
Study Sponsor  ICMJE Vesalio
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Vesalio
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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