NeVa ONE Registry Study

NEVA ONE One-Pass Reperfusion With the NeVa Stent-Retriever EMEA Registry

A prospective, open label study designed to assess the safety, performance and efficacy of thrombus removal in subjects presenting with acute ischemic stroke with the NeVa stent retrievers.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Device: NeVa Stent Retriever

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 600 subjects will be enrolled at up 30 sites.

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antoine Cuijpers; Phone Number: +31 6 51 55 99 37; Email: acuijpers@vesalio.com

Study Locations

• Argentina
  • Mendoza, Argentina
    • Recruiting
    • Hospital Espanol de Mendoza
    • Contact: Fernando Petra, MD
• Italy
  • Milan, Italy
    • Recruiting
    • Niguarda Hospital
    • Contact: Edoardo Boccardi; Phone Number: +39 3516775140
• United Arab Emirates
  • Abu Dhabi, United Arab Emirates
    • Recruiting
    • Cleveland Clinic Abu Dhabi
    • Contact: John Shelby, MD; Phone Number: +971 2 659 0200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Only subjects already treated with the NeVa thrombectomy devices can be considered for enrollment.

1. Age ≥18
2. NIHSS score ≥ 6
3. Pre-stroke mRS score ≤ 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:

   The patient should have confirmed LVO and salvageable penumbra. Any automated software for determine the volume of viable tissue is acceptable. patient selection should follow the following guidelines:

   • ASPECTS 6-10 if treatment started 0-6 hours from TLKW
   • ASPECTS 8-10 if treatment started 6-24 hours from TLKW
   • Ischemic core ≤ 50 cc
7. Subject or legal representative is able and willing to give informed consent within 72 hours after the intervention (may use independent physician consent in this timeframe and gain subject or legal representative consent later than 72 hours).

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention; NeVa Stent Retriever	Device: NeVa Stent Retriever; mechanical neurothrombectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First Pass Success Rate	The primary study endpoint is the first pass success rate with the NeVa device defined as eTICI score ≥ 2B & eTICI ≥2C	post-procedure day 0

Collaborators and Investigators

• Sponsor: Vesalio

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: September 4, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (Actual): September 24, 2020

Study Record Updates

• Last Update Posted (Estimate): January 16, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: stroke; Thrombus
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: VS-003/D

Drug and device information, study documents

• 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