CERENOVUS Neurothrombectomy Devices Registry

Cerebral Stroke Clinical Trial

— EXCELLENT  

Official title:

Embotrap eXtraction & Clot EvaLuation & Lesion Evaluation for NeuroThrombectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05591183
• Other study ID #: CNV_2017_02
• Status: Recruiting
• Start date: September 28, 2018
• Est. completion date: October 1, 2024

Study information

• Verified date: October 2022
• Source: Cerenovus, Part of DePuy Synthes Products, Inc.
• Contact: Erin O'Carroll- Godinez
• Phone: +1 949-433-9824
• Email: EOCarro3[@]its.jnj.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The objective of this study are to separately assess the effectiveness of the CERENOVUS neurothrombectomy devices (EmboTrap® Revascularization Device, and Large Bore Catheter/EMBOVAC Aspiration Catheter) in a real-world setting, as well as to explore correlations between patient comorbidities, clot characteristics, revascularization rates, and clinical outcomes..

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: October 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cerebral Stroke
• Stroke

Intervention

Device:
• EmboTrap® Revascularization Device
EmboTrap® Revascularization Device
• CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter
CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter

Locations

Country	Name	City	State
Belgium	Az Groeninge	Kortrijk
France	Hopital Roger Salengro - CHU Lille	Lille
Germany	Klinikum Dortmund gGmbH	Dortmund
Germany	Universitaetsklinikum Hamburg Eppendorf	Hamburg
Germany	Universitaetsmedizin Mainz	Mainz
Germany	Radprax MVZ Nordrhein GmbH	Solingen
Israel	Hadassah Medical Center	Jerusalem
Switzerland	Kantonsspital Aarau	Aarau
Switzerland	Centre Hospitalier Universitaire Vaudois (CHUV)	Lausanne
United Kingdom	Charing Cross Hospital	London
United States	Emory School of Medicine at Grady Memorial Hospital	Atlanta	Georgia
United States	The University of Alabama at Birmingham	Birmingham	Alabama
United States	Jacobs Institute/UB Neurosurgery, Inc.	Buffalo	New York
United States	Cleveland Clinic	Cleveland	Ohio
United States	Ohio Health	Columbus	Ohio
United States	Geisinger	Danville	Pennsylvania
United States	Geisinger Clinic	Danville	Pennsylvania
United States	Norton Neurology Institute	Elizabethtown	Kentucky
United States	Memorial Regional Hospital	Hollywood	Florida
United States	University of Texas Houston	Houston	Texas
United States	Baptist Medical Center	Jacksonville	Florida
United States	Lyerly Neurosurgery Baptist Health	Jacksonville	Florida
United States	TNVI	Knoxville	Tennessee
United States	University of Tennessee Medical Center	Knoxville	Tennessee
United States	Norton Healthcare	Louisville	Kentucky
United States	WellStar Health System	Marietta	Georgia
United States	Semmes Murphey Foundation	Memphis	Tennessee
United States	Banner Desert Medical Center	Mesa	Arizona
United States	University of Miami- Jackson Memorial Hospital	Miami	Florida
United States	Vanderbilt University Medical Center	Nashville	Missouri
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Advent Health Orlando	Orlando	Florida
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Barrow Neurological Institute at St. Joseph's Hospital	Phoenix	Arizona
United States	Texas Stroke Institute	Plano	Texas
United States	Oregon Health & Science University	Portland	Oregon
United States	Washington University in St. Louis	Saint Louis	Missouri
United States	Vascular Neurology of Southern California: Dr. M. Asif Taqi	Thousand Oaks	California
United States	Mercy Health St Vincent Medical Center	Toledo	Ohio
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Cerenovus, Part of DePuy Synthes Products, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  France,  Germany,  Israel,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful Revascularization	Assess cerebral revascularization using the modified Thrombolysis in Cerebral Infarction (mTICI) score at the end of the procedure.	1 day
Secondary	All-Cause Mortality	Summary of all mortality regardless of cause at 90 days post-procedure.	90 days
Secondary	Symptomatic Intracerebral Hemorrhage	Rate of intracranial hemorrhage as detected by brain imaging (CT/MR) measured 24 hours after intervention	24 hours
Secondary	Functional Independence	Modified Rankin Scale (mRS) of = 2; Modified Rankin Score (Scale from 0-6): 0 - No symptoms.; - No significant disability. Able to carry out all usual activities, despite some symptoms.; - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; - Moderate disability. Requires some help, but able to walk unassisted.; - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; - Dead	90 days