COMPLETED

CERENOVUS Neurothrombectomy Devices Registry

Conditions

Cerebral Stroke Mechanical thrombectomy EmboTrap Embovac Cereglide 71

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Embotrap eXtraction & Clot EvaLuation & Lesion Evaluation for NeuroThrombectomy

Quick Facts

Study Start:2018-09-28

Study Completion:2025-02-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT03685578

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	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

Inclusion Criteria

Exclusion 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)

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

Contacts and Locations

Principal Investigator

Adnan Siddiqui, MD, PhD

PRINCIPAL_INVESTIGATOR

University at Buffalo

Tommy Andersson, MD, PhD

PRINCIPAL_INVESTIGATOR

AZ Groeninge/ Karolinska University Hospital

Raul Nogueira, MD

PRINCIPAL_INVESTIGATOR

UPMC Stroke Institute

Study Locations (Sites)

The University of Alabama at Birmingham

Birmingham, Alabama, 35294

United States

Banner Desert Medical Center

Mesa, Arizona, 85202

United States

Barrow Neurological Institute at St. Joseph's Hospital

Phoenix, Arizona, 85013

United States

Vascular Neurology of Southern California: Dr. M. Asif Taqi

Thousand Oaks, California, 91360

United States

Memorial Regional Hospital

Hollywood, Florida, 33021

United States

Baptist Medical Center

Jacksonville, Florida, 32207

United States

Lyerly Neurosurgery Baptist Health

Jacksonville, Florida, 32207

United States

University of Miami- Jackson Memorial Hospital

Miami, Florida, 33133

United States

Advent Health Orlando

Orlando, Florida, 32803

United States

Emory School of Medicine at Grady Memorial Hospital

Atlanta, Georgia, 30303

United States

WellStar Health System

Marietta, Georgia, 30060

United States

Norton Neurology Institute

Elizabethtown, Kentucky, 42701

United States

Norton Healthcare

Louisville, Kentucky, 40241

United States

University of Massachusetts

Worcester, Massachusetts, 30303

United States

Vanderbilt University Medical Center

Nashville, Missouri, 37232

United States

Washington University in St. Louis

Saint Louis, Missouri, 63110

United States

Jacobs Institute/UB Neurosurgery, Inc.

Buffalo, New York, 14203

United States

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Ohio Health

Columbus, Ohio, 43214

United States

Mercy Health St Vincent Medical Center

Toledo, Ohio, 43608

United States

Oregon Health & Science University

Portland, Oregon, 97201

United States

Geisinger Clinic

Danville, Pennsylvania, 17822

United States

Geisinger

Danville, Pennsylvania, 17822

United States

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

United States

TNVI

Knoxville, Tennessee, 37902

United States

University of Tennessee Medical Center

Knoxville, Tennessee, 37920

United States

Semmes Murphey Foundation

Memphis, Tennessee, 38120

United States

University of Texas Houston

Houston, Texas, 77030

United States

Texas Stroke Institute

Plano, Texas, 75075

United States

Collaborators and Investigators

Sponsor: Cerenovus, Part of DePuy Synthes Products, Inc.

Adnan Siddiqui, MD, PhD, PRINCIPAL_INVESTIGATOR, University at Buffalo
Tommy Andersson, MD, PhD, PRINCIPAL_INVESTIGATOR, AZ Groeninge/ Karolinska University Hospital
Raul Nogueira, MD, PRINCIPAL_INVESTIGATOR, UPMC Stroke Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-09-28

Study Completion Date2025-02-20

Study Record Updates

Study Start Date2018-09-28

Study Completion Date2025-02-20

Terms related to this study

Keywords Provided by Researchers

Mechanical thrombectomy
EmboTrap
Embovac
Cereglide 71

Additional Relevant MeSH Terms

Cerebral Stroke