CERENOVUS Neurothrombectomy Devices Registry (EXCELLENT)

Cerenovus

Status: Enrolling

Conditions: Cerebral Stroke

Treatments: Device: CEREGLIDE 71 Intermediate Catheter; Device: EmboTrap® Revascularization Device; Device: CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter

Study type: Observational

Funder types: Industry

Identifiers

NCT03685578

CNV_2017_02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,000 participants in 1 patient group

Mechanical Thrombectomy

Description:

EmboTrap® Revascularization Device, CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter, CEREGLIDE 71 Intermediate Catheter

Treatment:

Device: CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter

Device: EmboTrap® Revascularization Device

Device: CEREGLIDE 71 Intermediate Catheter