CERENOVUS Neurothrombectomy Devices Registry

Study Overview
=================
Brief Summary
-----------------
A post-market registry evaluating the EmboTrap® Revascularization Device and CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter in acute ischemic stroke patients with confirmed intracranial large vessel occlusion.

Detailed Description
-----------------
The objective of this study are to separately assess the effectiveness of the CERENOVUS neurothrombectomy devices (EmboTrap® Revascularization Device, and Large Bore Catheter/EMBOVAC Aspiration Catheter) in a real-world setting, as well as to explore correlations between patient comorbidities, clot characteristics, revascularization rates, and clinical outcomes..

Official Title
-----------------
Embotrap eXtraction & Clot EvaLuation & Lesion Evaluation for NeuroThrombectomy

Conditions
-----------------
Cerebral Stroke

Intervention / Treatment
-----------------
* Device: EmboTrap® Revascularization Device
* Device: CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 The participant or the participant's legally authorized representative has signed and dated an Informed Consent Form. In the event that local regulations allow for alternative approaches of consent, these must be fulfilled as approved by the sponsor and site's ethics committee/regulatory authority (if applicable) Participants experiencing acute ischemic stroke with angiographic confirmation of Large Vessel Occlusion (LVO) A clinical decision has been made to use a CERENOVUS neurothrombectomy device (EmboTrap® Revascularization Device and/or Large Bore Catheter/EMBOVAC Aspiration Catheter) independently and prior to enrollment in the research study A CERENOVUS neurothrombectomy device is the first attempted primary device/technique for mechanical thrombectomy for the intracranial occlusion in the participant. The following primary devices/techniques are eligible for this study: a) EmboTrap® Revascularization Device alone b) EmboTrap® Revascularization Device + co-aspiration with the Large Bore Catheter/EMBOVAC Aspiration Catheter c) EmboTrap® Revascularization Device + co-aspiration with any other aspiration catheter d) Large Bore Catheter/EMBOVAC Aspiration Catheter alone (that is, direct aspiration with no stent retriever in the first attempted technique) Exclusion Criteria: Currently participating in an investigational (drug, device, etc) clinical trial that may confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible Confirmation of positive pregnancy test according to site specific standard of care (example, test, verbal communication)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mechanical Thrombectomy<br>EmboTrap® Revascularization Device, CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter | Device: EmboTrap® Revascularization Device<br>* EmboTrap® Revascularization Device<br>Device: CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter<br>* CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Revascularization | Assess cerebral revascularization using the modified Thrombolysis in Cerebral Infarction (mTICI) score at the end of the procedure. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-Cause Mortality | Summary of all mortality regardless of cause at 90 days post-procedure. | 90 days | 
| Symptomatic Intracerebral Hemorrhage | Rate of intracranial hemorrhage as detected by brain imaging (CT/MR) measured 24 hours after intervention | 24 hours | 
| Functional Independence | Modified Rankin Scale (mRS) of ≤ 2 Modified Rankin Score (Scale from 0-6): 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mechanical thrombectomy, EmboTrap, Embovac