CERENOVUS Neurothrombectomy Devices Registry

ID#: NCT03685578

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: September 28, 2018

End Date: October 01, 2024

Contact Information:
Erin O'Carroll- Godinez
+1 949-433-9824
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.

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)