Cerebral Stroke
Conditions
Keywords
Mechanical thrombectomy, EmboTrap, Embovac, Cereglide 71
Brief summary
A post-market registry evaluating the EmboTrap® Revascularization Device, CERENOVUS Large Bore Catheter/ EMBOVAC™ Aspiration Catheter, and CEREGLIDE 71 Intermediate Catheter in acute ischemic stroke patients with confirmed intracranial vessel occlusion.
Detailed description
The objective of this study are to separately assess the effectiveness of the CERENOVUS neurothrombectomy devices (EmboTrap® Revascularization Device, Large Bore Catheter/EMBOVAC Aspiration Catheter, and CEREGLIDE 71 Intermediate Catheter) in a real-world setting, as well as to explore correlations between patient comorbidities, clot characteristics, revascularization rates, and clinical outcomes.
Interventions
EmboTrap® Revascularization Device
DEVICECERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter
CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter
DEVICECEREGLIDE 71 Intermediate Catheter
CEREGLIDE 71 Intermediate Catheter
Sponsors
Cerenovus, Part of DePuy Synthes Products, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 2. 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) 3. Participants experiencing acute ischemic stroke with angiographic confirmation of intracranial vessel occlusion 4. A clinical decision has been made to use a CERENOVUS neurothrombectomy device (EmboTrap® Revascularization Device, Large Bore Catheter/ EMBOVAC Aspiration Catheter, or CEREGLIDE 71 Intermediate Catheter) independently and prior to enrollment in the research study 5. 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 or CEREGLIDE 71 Intermediate 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) e) CEREGLIDE 71 Intermediate Catheter alone (that is, direct aspiration with no stent retriever in the first attempted technique)
Exclusion criteria
1. 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 2. Confirmation of positive pregnancy test according to site specific standard of care (example, test, verbal communication) 3. Use of multiple stent retrievers on the first pass
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Revascularization | 1 day | Assess cerebral revascularization using the modified Thrombolysis in Cerebral Infarction (mTICI) score at the end of the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-Cause Mortality | 90 days | Summary of all mortality regardless of cause at 90 days post-procedure. |
| Symptomatic Intracerebral Hemorrhage | 24 hours | Rate of intracranial hemorrhage as detected by brain imaging (CT/MR) measured 24 hours after intervention |
| Functional Independence | 90 days | Modified Rankin Scale (mRS) of ≤ 2 Modified Rankin Score (Scale from 0-6): 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead |
Countries
Belgium, France, Germany, Israel, Switzerland, United Kingdom, United States
Outcome results
None listed