EXCELLENT: CERENOVUS Neurothrombectomy Devices Registry
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed 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..
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Mechanical Thrombectomy EmboTrap® Revascularization Device, CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter |
Device: EmboTrap® Revascularization Device
EmboTrap® Revascularization Device
Device: CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter
CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter
|
Outcome Measures
Primary Outcome Measures
- Successful Revascularization [1 day]
Assess cerebral revascularization using the modified Thrombolysis in Cerebral Infarction (mTICI) score at the end of the procedure.
Secondary Outcome Measures
- All-Cause Mortality [90 days]
Summary of all mortality regardless of cause at 90 days post-procedure.
- Symptomatic Intracerebral Hemorrhage [24 hours]
Rate of intracranial hemorrhage as detected by brain imaging (CT/MR) measured 24 hours after intervention
- Functional Independence [90 days]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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 Large Vessel Occlusion (LVO)
-
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
-
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:
-
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Alabama at Birmingham | Birmingham | Alabama | United States | 35294 |
| 2 | Banner Desert Medical Center | Mesa | Arizona | United States | 85202 |
| 3 | Barrow Neurological Institute at St. Joseph's Hospital | Phoenix | Arizona | United States | 85013 |
| 4 | Vascular Neurology of Southern California: Dr. M. Asif Taqi | Thousand Oaks | California | United States | 91360 |
| 5 | Memorial Regional Hospital | Hollywood | Florida | United States | 33021 |
| 6 | Baptist Medical Center | Jacksonville | Florida | United States | 32207 |
| 7 | Lyerly Neurosurgery Baptist Health | Jacksonville | Florida | United States | 32207 |
| 8 | University of Miami- Jackson Memorial Hospital | Miami | Florida | United States | 33133 |
| 9 | Advent Health Orlando | Orlando | Florida | United States | 32803 |
| 10 | Emory School of Medicine at Grady Memorial Hospital | Atlanta | Georgia | United States | 30303 |
| 11 | WellStar Health System | Marietta | Georgia | United States | 30060 |
| 12 | Norton Neurology Institute | Elizabethtown | Kentucky | United States | 42701 |
| 13 | Norton Healthcare | Louisville | Kentucky | United States | 40241 |
| 14 | University of Massachusetts | Worcester | Massachusetts | United States | 30303 |
| 15 | Vanderbilt University Medical Center | Nashville | Missouri | United States | 37232 |
| 16 | Washington University in St. Louis | Saint Louis | Missouri | United States | 63110 |
| 17 | Jacobs Institute/UB Neurosurgery, Inc. | Buffalo | New York | United States | 14203 |
| 18 | Icahn School of Medicine at Mount Sinai | New York | New York | United States | 10029 |
| 19 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 20 | Ohio Health | Columbus | Ohio | United States | 43214 |
| 21 | Mercy Health St Vincent Medical Center | Toledo | Ohio | United States | 43608 |
| 22 | Oregon Health & Science University | Portland | Oregon | United States | 97201 |
| 23 | Geisinger Clinic | Danville | Pennsylvania | United States | 17822 |
| 24 | Geisinger | Danville | Pennsylvania | United States | 17822 |
| 25 | Thomas Jefferson University | Philadelphia | Pennsylvania | United States | 19107 |
| 26 | TNVI | Knoxville | Tennessee | United States | 37902 |
| 27 | University of Tennessee Medical Center | Knoxville | Tennessee | United States | 37920 |
| 28 | Semmes Murphey Foundation | Memphis | Tennessee | United States | 38120 |
| 29 | University of Texas Houston | Houston | Texas | United States | 77030 |
| 30 | Texas Stroke Institute | Plano | Texas | United States | 75075 |
| 31 | Az Groeninge | Kortrijk | Belgium | 8500 | |
| 32 | Hopital Roger Salengro - CHU Lille | Lille | France | 59037 | |
| 33 | Klinikum Dortmund gGmbH | Dortmund | Germany | 44137 | |
| 34 | Universitaetsklinikum Hamburg Eppendorf | Hamburg | Germany | 20246 | |
| 35 | Universitaetsmedizin Mainz | Mainz | Germany | 55101 | |
| 36 | Radprax MVZ Nordrhein GmbH | Solingen | Germany | 42651 | |
| 37 | Hadassah Medical Center | Jerusalem | Israel | 91120 | |
| 38 | Kantonsspital Aarau | Aarau | Switzerland | 5001 | |
| 39 | Centre Hospitalier Universitaire Vaudois (CHUV) | Lausanne | Switzerland | CH-1011 | |
| 40 | Charing Cross Hospital | London | United Kingdom | W6 8RF |
Sponsors and Collaborators
- Cerenovus, Part of DePuy Synthes Products, Inc.
Investigators
- Principal Investigator: Adnan Siddiqui, MD, PhD, University at Buffalo
- Principal Investigator: Tommy Andersson, MD, PhD, AZ Groeninge/ Karolinska University Hospital
- Principal Investigator: Raul G Nogueira, MD, Grady Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CNV_2017_02