Registry for evaluating neurothrombectomy devices in stroke patients
Embotrap eXtraction & Clot EvaLuation & Lesion Evaluation for NeuroThrombectomy
This study is testing how well certain devices can help treat stroke patients with blocked blood vessels to see if they improve recovery and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cerenovus, Part of DePuy Synthes Products, Inc. Industry-sponsored |
| Locations | 40 sites (Birmingham, Alabama and 39 other locations) |
| Trial ID | NCT03685578 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to assess the effectiveness of the CERENOVUS neurothrombectomy devices, including the EmboTrap® Revascularization Device, Large Bore Catheter/EMBOVAC Aspiration Catheter, and CEREGLIDE 71 Intermediate Catheter, in patients with acute ischemic stroke and confirmed intracranial vessel occlusion. The study will collect real-world data to explore the relationship between patient comorbidities, clot characteristics, revascularization rates, and clinical outcomes. By analyzing these factors, the registry seeks to provide insights into the performance of these devices in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are experiencing an acute ischemic stroke with confirmed intracranial vessel occlusion.
Not a fit: Patients who do not have an intracranial vessel occlusion or are not undergoing mechanical thrombectomy with the specified devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could enhance the understanding of neurothrombectomy devices, potentially leading to improved treatment strategies for acute ischemic stroke patients.
How similar studies have performed: Other studies evaluating neurothrombectomy devices have shown promising results, indicating that this approach is supported by prior successful research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama and 39 other locations
- The University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- Banner Desert Medical Center — Mesa, Arizona, United States (Recruiting)
- Barrow Neurological Institute at St. Joseph's Hospital — Phoenix, Arizona, United States (Recruiting)
- Vascular Neurology of Southern California: Dr. M. Asif Taqi — Thousand Oaks, California, United States (Recruiting)
- Memorial Regional Hospital — Hollywood, Florida, United States (Recruiting)
- Baptist Medical Center — Jacksonville, Florida, United States (Recruiting)
- Lyerly Neurosurgery Baptist Health — Jacksonville, Florida, United States (Recruiting)
- University of Miami- Jackson Memorial Hospital — Miami, Florida, United States (Recruiting)
- Advent Health Orlando — Orlando, Florida, United States (Recruiting)
- Emory School of Medicine at Grady Memorial Hospital — Atlanta, Georgia, United States (Recruiting)
- WellStar Health System — Marietta, Georgia, United States (Recruiting)
- Norton Neurology Institute — Elizabethtown, Kentucky, United States (Recruiting)
- Norton Healthcare — Louisville, Kentucky, United States (Recruiting)
- University of Massachusetts — Worcester, Massachusetts, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Missouri, United States (Recruiting)
- Washington University in St. Louis — Saint Louis, Missouri, United States (Recruiting)
- Jacobs Institute/UB Neurosurgery, Inc. — Buffalo, New York, United States (Recruiting)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- Ohio Health — Columbus, Ohio, United States (Recruiting)
- Mercy Health St Vincent Medical Center — Toledo, Ohio, United States (Recruiting)
- Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
- Geisinger Clinic — Danville, Pennsylvania, United States (Recruiting)
- Geisinger — Danville, Pennsylvania, United States (Recruiting)
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Recruiting)
- Tnvi — Knoxville, Tennessee, United States (Recruiting)
- University of Tennessee Medical Center — Knoxville, Tennessee, United States (Recruiting)
- Semmes Murphey Foundation — Memphis, Tennessee, United States (Recruiting)
- University of Texas Houston — Houston, Texas, United States (Recruiting)
- Texas Stroke Institute — Plano, Texas, United States (Recruiting)
- Az Groeninge — Kortrijk, Belgium (Recruiting)
- Hopital Roger Salengro - CHU Lille — Lille, France (Recruiting)
- Klinikum Dortmund gGmbH — Dortmund, Germany (Recruiting)
- Universitaetsklinikum Hamburg Eppendorf — Hamburg, Germany (Recruiting)
- Universitaetsmedizin Mainz — Mainz, Germany (Recruiting)
- Radprax MVZ Nordrhein GmbH — Solingen, Germany (Recruiting)
- Hadassah Medical Center — Jerusalem, Israel (Recruiting)
- Kantonsspital Aarau — Aarau, Switzerland (Recruiting)
- Centre Hospitalier Universitaire Vaudois (CHUV) — Lausanne, Switzerland (Recruiting)
- Charing Cross Hospital — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Adnan Siddiqui, MD, PhD — University at Buffalo
- Study coordinator: Erin O'Carroll- Godinez
- Email: EOCarro3@its.jnj.com
- Phone: +1 949-433-9824
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.