Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
N/A
Funding Agency/Sponsor
Industry
Disease
Stroke
Enrollment Eligibility
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
Large Vessel Occlusion (LVO)
4. 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
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 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:
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)