Clinical trial NCT06964724: NeVa Retrospective Comparative SR Study
Official title: NeVa International, MulTi-center, Retrospective cOmparative Stent Retriever Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stroke Acute
Keywords: NeVa
Mechanical Thrombectomy
Lead sponsor: Vesalio
Sponsor class: INDUSTRY
First posted: 2025-05-09
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects suffering from acute ischemic stroke from large vessel occlusion treated with study device.

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?

Detailed description: NITRO is a multicenter, retrospective, comparative, non-inferiority, cohort study designed to compare NeVa SR with Control SR for safety and effectiveness when removing thrombus in subjects presenting with acute ischemic stroke (AIS) due to large vessel occlusion (LVO). The objective of the NeVa International, Multi-center, Retrospective Comparative stent retriever (SR) study (NITRO) study is to compare safety and effectiveness of the NeVa SR to commonly used SR with CE-mark, and US FDA clearance, to restore blood flow in patients experiencing acute ischemic stroke due to large intracranial vessel occlusion. NITRO aims to collect data describing real-world clinical practices when using SRs according to their indicated use within the indicated population. As such, the eligibility criteria define patients who are diagnosed with AIS and are indicated for endovascular MT aligning to the target population for the proposed device. The present study will include data from subjects treated with either NeVa SR or one of the Control SR. Control SR will include any SR commonly used in thrombectomy trials as first-line strategies and which represent CE-mark, and US FDA cleared stent retrievers.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Reperfusion Effectiveness
timeFrame: Procedural
Secondary outcomes:
measure: Procedural symptomatic bleeding events
timeFrame: Within 24 hours post intervention
measure: Procedure Safety
timeFrame: Within 24 hours post intervention
measure: Device relationship to serious adverse events
timeFrame: Within 24 hours post intervention
Other outcomes:
measure: Functional Independence at 90 days
timeFrame: At 90 Days
measure: 90-day Mortality
timeFrame: Within 90 days post intervention
Locations:
Study officials:
affiliation: Vesalio
name: Antoine Cuijpers, MSc
role: STUDY_DIRECTOR
References: