CERENOVUS Neurothrombectomy Devices Registry

Completed

Conditions studied: Cerebral Stroke

In brief

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.

Key facts

Study ID

NCT03685578

Run by

Cerenovus, Part of DePuy Synthes Products, Inc.

People needed

2000

Starts

2018-09-28

Expected to finish

2025-02-20

Last updated by the study team

2025-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 intracranial vessel occlusion
• 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
• 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)

You may not qualify if…

• 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)
• Use of multiple stent retrievers on the first pass

Where it is running

• The University of Alabama at Birmingham — Birmingham, Alabama, United States
• Banner Desert Medical Center — Mesa, Arizona, United States
• Barrow Neurological Institute at St. Joseph's Hospital — Phoenix, Arizona, United States
• Vascular Neurology of Southern California: Dr. M. Asif Taqi — Thousand Oaks, California, United States
• Memorial Regional Hospital — Hollywood, Florida, United States
• Baptist Medical Center — Jacksonville, Florida, United States
• Lyerly Neurosurgery Baptist Health — Jacksonville, Florida, United States
• University of Miami- Jackson Memorial Hospital — Miami, Florida, United States
• Advent Health Orlando — Orlando, Florida, United States
• Emory School of Medicine at Grady Memorial Hospital — Atlanta, Georgia, United States
• WellStar Health System — Marietta, Georgia, United States
• Norton Neurology Institute — Elizabethtown, Kentucky, United States
• Norton Healthcare — Louisville, Kentucky, United States
• University of Massachusetts — Worcester, Massachusetts, United States
• Vanderbilt University Medical Center — Nashville, Missouri, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• Jacobs Institute/UB Neurosurgery, Inc. — Buffalo, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Ohio Health — Columbus, Ohio, United States
• Mercy Health St Vincent Medical Center — Toledo, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Geisinger Clinic — Danville, Pennsylvania, United States
• Geisinger — Danville, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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