NCT04562194

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach
3 countries

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jul 2020Jun 2027

Study Start

First participant enrolled

July 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 24, 2020

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

6.5 years

First QC Date

September 4, 2020

Last Update Submit

March 30, 2026

Conditions

Acute Ischemic Stroke

Keywords

Thrombusstroke

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Intervention

OTHER

NeVa Stent Retriever

Device: NeVa Stent Retriever

Interventions

NeVa Stent RetrieverDEVICE

mechanical neurothrombectomy

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Only subjects already treated with the NeVa thrombectomy devices can be considered for enrollment.
  • Age ≥18
  • NIHSS score ≥ 6
  • Pre-stroke mRS score ≤ 1
  • 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.
  • Thrombectomy procedure can be initiated within 24 hours from symptom onset (defined as time last known well \[TLKW\])
  • 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
  • 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).

You may not qualify if:

  • 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).
  • Cardiopulmonary resuscitation, significant cardiac arrhythmia, evidence of ongoing myocardial infarction, concern for pre- treatment pulmonary aspiration.
  • Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories
  • Cerebral vasculitis
  • History of severe allergy to contrast medium.
  • Known allergy to NeVa materials (nitinol, stainless steel)
  • Suspicion of aortic dissection, septic embolus, or bacterial endocarditis
  • Systemic infection
  • Significant mass effect with midline shift
  • Evidence of intracranial tumor (except small meningioma)
  • Inability to deploy NeVA device for at least one pass for any other reason
  • Life expectancy less than 6 months
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Espanol de Mendoza

Mendoza, Argentina

RECRUITING

Niguarda Hospital

Milan, Italy

RECRUITING

Cleveland Clinic Abu Dhabi

Abu Dhabi, United Arab Emirates

RECRUITING

MeSH Terms

Conditions

Ischemic StrokeThrombosisStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesEmbolism and Thrombosis

Central Study Contacts

Antoine Cuijpers

CONTACT

+31 6 51 55 99 37acuijpers@vesalio.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2020

First Posted

September 24, 2020

Study Start

July 1, 2020

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

IT(1)AR(1)AE(1)