CERENOVUS Neurothrombectomy Devices Registry

Launched by · Oct 19, 2022

Keywords

ClinConnect Summary

The CERENOVUS Neurothrombectomy Devices Registry is a clinical trial aimed at studying two specific devices, the EmboTrap® Revascularization Device and the CERENOVUS Large Bore Catheter/EMBOVAC Aspiration Catheter, used to treat patients who have suffered an acute ischemic stroke due to a blockage in a large blood vessel in the brain. The trial is currently recruiting participants aged 18 and older who have experienced this type of stroke and for whom a healthcare provider has decided to use one of these devices to help restore blood flow.

To participate, you must be at least 18 years old and have given consent to join the study. If you're currently in another clinical trial or are pregnant, you won’t be eligible. Those who join can expect to receive treatment with one of the devices mentioned above, and the study will help gather important information about the effectiveness and safety of these devices in treating strokes. This research is crucial for improving future treatments for stroke patients.

Gender

All

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)