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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mechanical Thrombectomy | EmboTrap® Revascularization Device, CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter, CEREGLIDE 71 Intermediate Catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EmboTrap® Revascularization Device | Device | EmboTrap® Revascularization Device |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Successful Revascularization | Assess cerebral revascularization using the modified Thrombolysis in Cerebral Infarction (mTICI) score at the end of the procedure. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| All-Cause Mortality | Summary of all mortality regardless of cause at 90 days post-procedure. | 90 days |
| Symptomatic Intracerebral Hemorrhage | Rate of intracranial hemorrhage as detected by brain imaging (CT/MR) measured 24 hours after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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Acute Ischemic Stroke patients with angiographic confirmation of intracranial vessel occlusion.
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| Name | Affiliation | Role |
|---|---|---|
| Adnan Siddiqui, MD, PhD | University at Buffalo | Principal Investigator |
| Tommy Andersson, MD, PhD | AZ Groeninge/ Karolinska University Hospital | Principal Investigator |
| Raul Nogueira, MD | UPMC Stroke Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Banner Desert Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39559856 | Derived | Nogueira RG, Andersson T, Haussen DC, Yoo AJ, Hanel RA, Zaidat OO, Hacke W, Jovin TG, Fiehler J, De Meyer SF, Brinjikji W, Doyle KM, Kallmes DF, Liebeskind DS, Virmani R, Kokoszka MA, Inoa V, Humphries W, Woodward KB, Jabbour PM, Francois O, Levy EI, Bozorgchami H, Boor S, Cohen JE, Dashti SR, Taqi MA, Budzik RF, Schirmer CM, Hussain MS, Estrade L, De Leacy RA, Puri AS, Chitale RV, Brekenfeld C, Siddiqui AH. EXCELLENT Registry: A Prospective, Multicenter, Global Registry of Endovascular Stroke Treatment With the EMBOTRAP Device. Stroke. 2024 Dec;55(12):2804-2814. doi: 10.1161/STROKEAHA.124.047324. Epub 2024 Nov 19. | |
| 38152640 |
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thrombus / clot
| CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter |
| Device |
CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter |
|
| CEREGLIDE 71 Intermediate Catheter | Device | CEREGLIDE 71 Intermediate Catheter |
|
| 24 hours |
| Functional Independence | Modified Rankin Scale (mRS) of ≤ 2 Modified Rankin Score (Scale from 0-6): 0 - No symptoms.
| 90 days |
| 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 | St 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 |
| Az Groeninge | Kortrijk | 8500 | Belgium |
| Hopital Roger Salengro - CHU Lille | Lille | 59037 | France |
| Klinikum Dortmund gGmbH | Dortmund | 44137 | Germany |
| Universitaetsklinikum Hamburg Eppendorf | Hamburg | 20246 | Germany |
| Universitaetsmedizin Mainz | Mainz | 55101 | Germany |
| Radprax MVZ Nordrhein GmbH | Solingen | 42651 | Germany |
| Hadassah Medical Center | Jerusalem | 91120 | Israel |
| Kantonsspital Aarau | Aarau | 5001 | Switzerland |
| Centre Hospitalier Universitaire Vaudois (CHUV) | Lausanne | CH-1011 | Switzerland |
| Charing Cross Hospital | London | W6 8RF | United Kingdom |
| Derived |
| Bilgin C, Dai D, Johnson C, Mereuta OM, Kallmes DF, Brinjikji W, Kadirvel R. Quality assessment of histopathological stainings on prolonged formalin fixed thrombus tissues retrieved by mechanical thrombectomy. Front Neurol. 2023 Dec 13;14:1223947. doi: 10.3389/fneur.2023.1223947. eCollection 2023. |
| 34645704 | Derived | 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. |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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