Clinical trial NCT03685578: CERENOVUS Neurothrombectomy Devices Registry
Official title: Embotrap eXtraction & Clot EvaLuation & Lesion Evaluation for NeuroThrombectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Stroke
Keywords: Mechanical thrombectomy
EmboTrap
Embovac
Cereglide 71
Lead sponsor: Cerenovus, Part of DePuy Synthes Products, Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-26
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute Ischemic Stroke patients with angiographic confirmation of intracranial vessel occlusion.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Successful Revascularization
timeFrame: 1 day
Secondary outcomes:
measure: All-Cause Mortality
timeFrame: 90 days
measure: Symptomatic Intracerebral Hemorrhage
timeFrame: 24 hours
measure: Functional Independence
timeFrame: 90 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: Mesa
country: United States
facility: Banner Desert Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Barrow Neurological Institute at St. Joseph's Hospital
state: Arizona
city: Thousand Oaks
country: United States
facility: Vascular Neurology of Southern California: Dr. M. Asif Taqi
state: California
city: Hollywood
country: United States
facility: Memorial Regional Hospital
state: Florida
city: Jacksonville
country: United States
facility: Baptist Medical Center
state: Florida
city: Jacksonville
country: United States
facility: Lyerly Neurosurgery Baptist Health
state: Florida
city: Miami
country: United States
facility: University of Miami- Jackson Memorial Hospital
state: Florida
city: Orlando
country: United States
facility: Advent Health Orlando
state: Florida
city: Atlanta
country: United States
facility: Emory School of Medicine at Grady Memorial Hospital
state: Georgia
city: Marietta
country: United States
facility: WellStar Health System
state: Georgia
city: Elizabethtown
country: United States
facility: Norton Neurology Institute
state: Kentucky
city: Louisville
country: United States
facility: Norton Healthcare
state: Kentucky
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Buffalo
country: United States
facility: Jacobs Institute/UB Neurosurgery, Inc.
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio Health
state: Ohio
city: Toledo
country: United States
facility: Mercy Health St Vincent Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Danville
country: United States
facility: Geisinger Clinic
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Knoxville
country: United States
facility: TNVI
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Memphis
country: United States
facility: Semmes Murphey Foundation
state: Tennessee
city: Houston
country: United States
facility: University of Texas Houston
state: Texas
city: Plano
country: United States
facility: Texas Stroke Institute
state: Texas
city: Kortrijk
country: Belgium
facility: Az Groeninge
city: Lille
country: France
facility: Hopital Roger Salengro - CHU Lille
city: Dortmund
country: Germany
facility: Klinikum Dortmund gGmbH
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg Eppendorf
city: Mainz
country: Germany
facility: Universitaetsmedizin Mainz
city: Solingen
country: Germany
facility: Radprax MVZ Nordrhein GmbH
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois (CHUV)
city: London
country: United Kingdom
facility: Charing Cross Hospital
Study officials:
affiliation: University at Buffalo
name: Adnan Siddiqui, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: AZ Groeninge/ Karolinska University Hospital
name: Tommy Andersson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UPMC Stroke Institute
name: Raul Nogueira, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Siddiqui AH, Waqas M, Brinjikji W, De Meyer SF, Doyle K, Fiehler J, Hacke W, Hanel RA, Jovin TG, Liebeskind DS, Yoo AJ, Zaidat OO, Andersson T, Nogueira RG. Embotrap Extraction & Clot Evaluation & Lesion Evaluation for NeuroThrombectomy (EXCELLENT) Registry design and methods. J Neurointerv Surg. 2022 Aug;14(8):783-787. doi: 10.1136/neurintsurg-2021-017671. Epub 2021 Oct 13.