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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03927001

Recruitment Status Recruiting

First Posted April 25, 2019

Last update posted August 17, 2020

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:Acute Ischemic Stroke
  • Intervention/Treatment: Device: NeVa Stent Retrievers
  • Phase: N/A
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
  • Study Type: Interventional
  • Estimated Enrollment: 150 participants
  • 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 2019
  • Estimated Primary Completion Date: December 2021
  • Estimated Study Completion Date: December 2021
Arms and interventions
Arm Intervention/treatment
Other: 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
  • Ages Eligible for Study: 18 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

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

Locations

Spain
Vall d'Hebron
Barcelona

Sponsors and Collaborators

Vesalio

More Information
  • Responsible Party: Vesalio
  • ClinicalTrials.gov Identifier: NCT03927001 History of Changes
  • 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
  • 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