NeVa Retrospective Comparative SR Study

NCT06964724 | Active Not Recruiting

• 1 other identifier: VS-010
• Study Type: observational
• Target: 800
• Locations: 5 countries
• Sites: 5

Brief Summary

To compare safety and effectiveness of NeVa Stent Retriever (SR) to Control SR in the treatment of stroke caused by large vessel occlusion. The main questions it aims to answer are: How do recanalization rates for NeVa SR compare with those of the Control SR? How does NeVa SR safety compare with Control SR safety?

Conditions

Stroke Acute

Keywords

NeVa; Mechanical Thrombectomy

Outcome Measures

Primary Outcomes (1)

• Reperfusion Effectiveness

  Number of patients with a Modified Thrombolysis in cerebral infarction (mTICI) ≥2B and mTICI≥2C recanalization after 1st pass and at end of procedure

  Procedural

Secondary Outcomes (3)

• Procedural symptomatic bleeding events

  Within 24 hours post intervention

• Procedure Safety

  Within 24 hours post intervention

• Device relationship to serious adverse events

  Within 24 hours post intervention

Other Outcomes (2)

• Functional Independence at 90 days

  At 90 Days

• 90-day Mortality

  Within 90 days post intervention

Study Arms (1)

Patients experiencing acute ischemic stroke due to large vessel occlusion

According to Guidelines AIS patients due to LVO should receive mechanical thrombectomy (with a stent retriever) under certain conditions.

Procedure: Mechanical thrombectomy

Interventions

Mechanical thrombectomy PROCEDURE

Mechanical thrombectomy with stent retriever

Patients experiencing acute ischemic stroke due to large vessel occlusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects suffering from acute ischemic stroke from large vessel occlusion treated with study device.

You may qualify if:

• Treatment during the enrollment period
• Age ≥18
• Baseline modified Thrombolysis in Cerebral Infarction (mTICI) score ≤ 1
• Pre-stroke modified Rankin score (mRS) of 0 or 1
• Internal Carotid Artery (ICA), Middle Cerebral Artery (first segment M1/ second segment M2), basilar artery or vertebral artery occlusion
• National Institutes of Health Stroke Scale (NIHSS) score ≥ 8 and ≤ 25
• Thrombectomy procedure initiated within 8h of Time Last Known Well (TLKW)
• Intravenous Tissue Plasminogen Activator (IV-tPA) failed, given within 3h of TLKW, or ineligibility for thrombolytic drug

You may not qualify if:

• First line contact aspiration alone or non-study device as first-line device

Sponsors & Collaborators

• Vesalio: lead

Study Sites (5)

Hospital Espanol de Mendoza

Mendoza, 5500, Argentina

Location

CHU LIege

Liège, 4000, Belgium

Location

UK Munster

Münster, 48149, Germany

Location

Republican Vilnius University Hospital

Vilnius, 04130, Lithuania

Location

İstanbul Aydrn Üniversitesi

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Antoine Cuijpers, MSc

  Vesalio

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: May 9, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

DE (1); AR (1); TU (1); LI (1); BE (1)