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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanical thrombectomy | Procedure | Mechanical thrombectomy with stent retriever |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural symptomatic bleeding events | Number of patients experiencing symptomatic intracranial hemorrhage (sICH) | Within 24 hours post intervention |
| Procedure Safety | Number of patients experiencing procedure related serious Adverse Events (PRSAE) |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Independence at 90 days | Number of patients with a Modified Rankin Scale (mRS) 0-2 | At 90 Days |
| 90-day Mortality | Number of patients that died at 90-days from any cause |
Inclusion Criteria:
Exclusion Criteria:
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Subjects suffering from acute ischemic stroke from large vessel occlusion treated with study device.
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| Name | Affiliation | Role |
|---|---|---|
| Antoine Cuijpers, MSc | Vesalio | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Espanol de Mendoza | Mendoza | 5500 | Argentina | |||
| CHU LIege |
At this stage not yet discussed how or at which URL the Protocol defined Endpoints will be made available.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Within 24 hours post intervention |
| Device relationship to serious adverse events | Number of patients experiencing a serious adverse device effect (SADE) | Within 24 hours post intervention |
| Within 90 days post intervention |
| Liège |
| 4000 |
| Belgium |
| UK Munster | Münster | 48149 | Germany |
| Republican Vilnius University Hospital | Vilnius | 04130 | Lithuania |
| İstanbul Aydrn Üniversitesi | Istanbul | Turkey (Türkiye) |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |