Status:
ACTIVE_NOT_RECRUITING
NeVa Retrospective Comparative SR Study
Lead Sponsor:
Vesalio
Conditions:
Stroke Acute
Eligibility:
All Genders
18+ years
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 recanaliza...
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...
Eligibility Criteria
Inclusion
- 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
- First line contact aspiration alone or non-study device as first-line device
Key Trial Info
Start Date :
June 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 15 2026
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT06964724
Start Date
June 15 2025
End Date
June 15 2026
Last Update
November 20 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Espanol de Mendoza
Mendoza, Argentina, 5500
2
CHU LIege
Liège, Belgium, 4000
3
UK Munster
Münster, Germany, 48149
4
Republican Vilnius University Hospital
Vilnius, Lithuania, 04130