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The purpose of this registry is to assess clinical outcomes, and different factors that may affect these clinical outcomes such as systems of care, associated with the use of Covidien market-released neurothrombectomy devices intended to restore blood flow in patients experiencing acute ischemic stroke due to large intracranial vessel occlusion.
This is a prospective, multi-center, non-randomized, observational registry of acute ischemic stroke patients that have or will undergo treatment with the use of a Covidien market-released neurothrombectomy device (as the initial device used to remove the thrombus) within 8 hours of stroke symptom onset, at the discretion of the investigator and independent of participation in this registry. This registry may enroll up to 1000 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medtronic NV market-released device | Patients experiencing an acute ischemic stroke due to a large vessel occlusion treated with a Medtronic Neurovascular market-released neurothrombectomy device. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Assessed for Revascularization With mTICI Grades 2b-3 | Assess revascularization using modified Thrombolysis in Cerebral Infarction (mTICI) score at the end of the procedure. This scale determines the response of therapy for ischemic stroke based on angiographic appearances of the treated occluded vessel and the distal branches. Classification: grade 0: no perfusion grade 1: antegrade reperfusion past the initial occlusion, but limited distal branch filling with little or slow distal reperfusion grade 2a: antegrade reperfusion of less than half of the occluded target artery previously ischemic territory grade 2b: antegrade reperfusion of more than half of the previously occluded target artery ischemic territory grade 3: complete antegrade reperfusion of the previously occluded target artery ischemic territory, with absence of visualized occlusion in all distal branches (higher values represent better outcomes) | Day 0-At the completion of the thrombectomy procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Neurological Events of Interest | Evaluate events causing neurological deterioration (defined as ≥ 4 worsening points from baseline on the NIHSS scale) | up to 90 days post index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Mortality | up to 90 days post index procedure | |
| Number of Participants With Good Functional Outcome (mRS 0-2) | Score based on modified Rankin Scale (mRS). The modified Rankin Scale (mRS) is a scale used to measure the degree of disability or dependence in daily activities of people who has had a stroke. Clasiffication: 0 - No symptoms.
|
Inclusion Criteria:
Exclusion Criteria:
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Acute Ischemic Stroke Patients
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| Name | Affiliation | Role |
|---|---|---|
| Nils Mueller-Kronast, M.D. | Advanced Neuroscience Network/Tenet South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center | Phoenix | Arizona | 85006 | United States | ||
| University of Arizona Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34504469 | Derived | Jahan R, Liebeskind DS, Zaidat OO, Mueller-Kronast NH, Froehler MT, Saver JL. Stent Retriever Thrombectomy for Anterior vs. Posterior Circulation Ischemic Stroke: Analysis of the STRATIS Registry. Front Neurol. 2021 Aug 23;12:706130. doi: 10.3389/fneur.2021.706130. eCollection 2021. | |
| 34311566 | Derived | Jumaa MA, Castonguay AC, Salahuddin H, Jadhav AP, Limaye K, Farooqui M, Zaidi SF, Mueller-Kronast N, Liebeskind DS, Zaidat OO, Ortega-Gutierrez S. Middle Cerebral Artery M2 Thrombectomy in the STRATIS Registry. Stroke. 2021 Nov;52(11):3490-3496. doi: 10.1161/STROKEAHA.120.033951. Epub 2021 Jul 27. |
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Only multi center data will be available
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-Randomized | Observation registry. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 90 days post index procedure |
| Incidence of Device Related Serious Adverse Events | Any device-related serious adverse events associated with the use of a Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure up to 90 days post index stroke procedure. | up to 90 days post index procedure |
| Time to Revascularization | Arterial access puncture to revascularization measured in minutes. Lower values indicate shorter time to revascularization and vice versa. | Day 0-At the completion of the thrombectomy procedure |
| Incidence of Procedure Related Serious Adverse Events | Any procedure related serious adverse events occurring upon insertion of a Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure up to 90 days post index stroke procedure. | up to 90 days post index procedure |
| Tucson |
| Arizona |
| 85724 |
| United States |
| University of California Irvine | Irvine | California | 92697 | United States |
| University of California Los Angeles | Los Angeles | California | 90095 | United States |
| Mercy San Juan Medical Center/ Mercy General | Sacramento | California | 95816 | United States |
| California Pacific Medical Center | San Francisco | California | 94115 | United States |
| Los Robles Medical Center | Thousand Oaks | California | 91360 | United States |
| Advanced Neuroscience Network/Tenet South Florida | Delray Beach | Florida | 33484 | United States |
| South Broward Hospital | Hollywood | Florida | 33021 | United States |
| Baptist Medical Center - Jacksonville | Jacksonville | Florida | 32207 | United States |
| University of Miami Hospital | Miami | Florida | 33136 | United States |
| Baptist Hospital of Miami | Miami | Florida | 33176 | United States |
| Florida Hospital | Orlando | Florida | 32803 | United States |
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States |
| WellStar Kennestone Regional Medical Center | Marietta | Georgia | 30060 | United States |
| Presence St. Joseph Medical Center | Joliet | Illinois | 60435 | United States |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | United States |
| Baptist Health Lexington/Central Baptist | Lexington | Kentucky | 40503 | United States |
| University of Kentucky Hospital | Lexington | Kentucky | 40536 | United States |
| Baptist Hospital Louisville | Louisville | Kentucky | 40207 | United States |
| Norton Healthcare | Louisville | Kentucky | 40241 | United States |
| Maine Medical Center | Portland | Maine | 04102 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| St. John Providence Hospital, Detroit | Detroit | Michigan | 48236 | United States |
| McLaren Flint | Flint | Michigan | 48532 | United States |
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Mayo Clinic, Rochester | Rochester | Minnesota | 55905 | United States |
| St. Dominic's - Jackson Memorial Hospital | Jackson | Mississippi | 39216 | United States |
| St. Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| Barnes Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| Buffalo General Medical Center | Buffalo | New York | 14203 | United States |
| Crouse Hospital | Syracuse | New York | 13210 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28207 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| OhioHealth Riverside Methodist Hospital | Columbus | Ohio | 43214 | United States |
| ProMedica Toledo Hospital | Toledo | Ohio | 43606 | United States |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225 | United States |
| Oregon Health and Science University Hospital | Portland | Oregon | 97239 | United States |
| Geisinger Clinic | Danville | Pennsylvania | 17822 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Erlanger Medical Center | Chattanooga | Tennessee | 37403 | United States |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Valley Baptist Medical Center | Harlingen | Texas | 78550 | United States |
| Memorial Hermann Texas Medical Center | Houston | Texas | 77030 | United States |
| Methodist Hospital, Houston | Houston | Texas | 77030 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98111 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| West Virginia University/ Ruby Memorial | Morgantown | West Virginia | 26506 | United States |
| Aurora Hospital, Milwaukee | Milwaukee | Wisconsin | 53215 | United States |
| Froedtert Hospital | Milwaukee | Wisconsin | 53226 | United States |
| 34078106 | Derived | Zaidat OO, Liebeskind DS, Jadhav AP, Ortega-Gutierrez S, Nguyen TN, Haussen DC, Yavagal DR, Froehler MT, Jahan R, Nogueira RG, Yao TL, Alenzi BA, Bushnaq S, Mueller-Kronast NH. Impact of Age and Alberta Stroke Program Early Computed Tomography Score 0 to 5 on Mechanical Thrombectomy Outcomes: Analysis From the STRATIS Registry. Stroke. 2021 Jul;52(7):2220-2228. doi: 10.1161/STROKEAHA.120.032430. Epub 2021 Jun 3. |
| 32385089 | Derived | Mueller-Kronast N, Froehler MT, Jahan R, Zaidat O, Liebeskind D, Saver JL; STRATIS Investigators. Impact of EMS bypass to endovascular capable hospitals: geospatial modeling analysis of the US STRATIS registry. J Neurointerv Surg. 2020 Nov;12(11):1058-1063. doi: 10.1136/neurintsurg-2019-015593. Epub 2020 May 8. |
| 30776994 | Derived | Zaidat OO, Mueller-Kronast NH, Hassan AE, Haussen DC, Jadhav AP, Froehler MT, Jahan R, Ali Aziz-Sultan M, Klucznik RP, Saver JL, Hellinger FR Jr, Yavagal DR, Yao TL, Gupta R, Martin CO, Bozorgchami H, Kaushal R, Nogueira RG, Gandhi RH, Peterson EC, Dashti S, Given CA 2nd, Mehta BP, Deshmukh V, Starkman S, Linfante I, McPherson SH, Kvamme P, Grobelny TJ, Hussain MS, Thacker I, Vora N, Chen PR, Monteith SJ, Ecker RD, Schirmer CM, Sauvageau E, Chebl AB, Derdeyn CP, Maidan L, Badruddin A, Siddiqui AH, Dumont TM, Alhajeri A, Taqi MA, Asi K, Carpenter J, Boulos A, Jindal G, Puri AS, Chitale R, Deshaies EM, Robinson D, Kallmes DF, Baxter BW, Jumaa M, Sunenshine P, Majjhoo A, English JD, Suzuki S, Fessler RD, Delgado-Almandoz J, Martin JC, Liebeskind DS; STRATIS Investigators. Impact of Balloon Guide Catheter Use on Clinical and Angiographic Outcomes in the STRATIS Stroke Thrombectomy Registry. Stroke. 2019 Mar;50(3):697-704. doi: 10.1161/STROKEAHA.118.021126. |
| 30626287 | Derived | Zaidat OO, Haussen DC, Hassan AE, Jadhav AP, Mehta BP, Mokin M, Mueller-Kronast NH, Froehler MT. Impact of Stent Retriever Size on Clinical and Angiographic Outcomes in the STRATIS Stroke Thrombectomy Registry. Stroke. 2019 Feb;50(2):441-447. doi: 10.1161/STROKEAHA.118.022987. |
| 28943516 | Derived | Froehler MT, Saver JL, Zaidat OO, Jahan R, Aziz-Sultan MA, Klucznik RP, Haussen DC, Hellinger FR Jr, Yavagal DR, Yao TL, Liebeskind DS, Jadhav AP, Gupta R, Hassan AE, Martin CO, Bozorgchami H, Kaushal R, Nogueira RG, Gandhi RH, Peterson EC, Dashti SR, Given CA 2nd, Mehta BP, Deshmukh V, Starkman S, Linfante I, McPherson SH, Kvamme P, Grobelny TJ, Hussain MS, Thacker I, Vora N, Chen PR, Monteith SJ, Ecker RD, Schirmer CM, Sauvageau E, Abou-Chebl A, Derdeyn CP, Maidan L, Badruddin A, Siddiqui AH, Dumont TM, Alhajeri A, Taqi MA, Asi K, Carpenter J, Boulos A, Jindal G, Puri AS, Chitale R, Deshaies EM, Robinson DH, Kallmes DF, Baxter BW, Jumaa MA, Sunenshine P, Majjhoo A, English JD, Suzuki S, Fessler RD, Delgado Almandoz JE, Martin JC, Mueller-Kronast NH; STRATIS Investigators. Interhospital Transfer Before Thrombectomy Is Associated With Delayed Treatment and Worse Outcome in the STRATIS Registry (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke). Circulation. 2017 Dec 12;136(24):2311-2321. doi: 10.1161/CIRCULATIONAHA.117.028920. Epub 2017 Sep 24. |
| 28830971 | Derived | Mueller-Kronast NH, Zaidat OO, Froehler MT, Jahan R, Aziz-Sultan MA, Klucznik RP, Saver JL, Hellinger FR Jr, Yavagal DR, Yao TL, Liebeskind DS, Jadhav AP, Gupta R, Hassan AE, Martin CO, Bozorgchami H, Kaushal R, Nogueira RG, Gandhi RH, Peterson EC, Dashti SR, Given CA 2nd, Mehta BP, Deshmukh V, Starkman S, Linfante I, McPherson SH, Kvamme P, Grobelny TJ, Hussain MS, Thacker I, Vora N, Chen PR, Monteith SJ, Ecker RD, Schirmer CM, Sauvageau E, Abou-Chebl A, Derdeyn CP, Maidan L, Badruddin A, Siddiqui AH, Dumont TM, Alhajeri A, Taqi MA, Asi K, Carpenter J, Boulos A, Jindal G, Puri AS, Chitale R, Deshaies EM, Robinson DH, Kallmes DF, Baxter BW, Jumaa MA, Sunenshine P, Majjhoo A, English JD, Suzuki S, Fessler RD, Delgado Almandoz JE, Martin JC, Haussen DC; STRATIS Investigators. Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke: Primary Results of the STRATIS Registry. Stroke. 2017 Oct;48(10):2760-2768. doi: 10.1161/STROKEAHA.117.016456. Epub 2017 Aug 22. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Subjects enrolled |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Assessed for Revascularization With mTICI Grades 2b-3 | Assess revascularization using modified Thrombolysis in Cerebral Infarction (mTICI) score at the end of the procedure. This scale determines the response of therapy for ischemic stroke based on angiographic appearances of the treated occluded vessel and the distal branches. Classification: grade 0: no perfusion grade 1: antegrade reperfusion past the initial occlusion, but limited distal branch filling with little or slow distal reperfusion grade 2a: antegrade reperfusion of less than half of the occluded target artery previously ischemic territory grade 2b: antegrade reperfusion of more than half of the previously occluded target artery ischemic territory grade 3: complete antegrade reperfusion of the previously occluded target artery ischemic territory, with absence of visualized occlusion in all distal branches (higher values represent better outcomes) | 824 participants contributed to this analysis | Posted | Count of Participants | Participants | Day 0-At the completion of the thrombectomy procedure |
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| Secondary | Incidence of Neurological Events of Interest | Evaluate events causing neurological deterioration (defined as ≥ 4 worsening points from baseline on the NIHSS scale) | Posted | Count of Participants | Participants | up to 90 days post index procedure |
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| Other Pre-specified | All-cause Mortality | Posted | Count of Participants | Participants | up to 90 days post index procedure |
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| Other Pre-specified | Number of Participants With Good Functional Outcome (mRS 0-2) | Score based on modified Rankin Scale (mRS). The modified Rankin Scale (mRS) is a scale used to measure the degree of disability or dependence in daily activities of people who has had a stroke. Clasiffication: 0 - No symptoms.
| 906 participants contributed to this analysis | Posted | Count of Participants | Participants | 90 days post index procedure |
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| Other Pre-specified | Incidence of Device Related Serious Adverse Events | Any device-related serious adverse events associated with the use of a Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure up to 90 days post index stroke procedure. | Posted | Count of Participants | Participants | up to 90 days post index procedure |
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| Other Pre-specified | Time to Revascularization | Arterial access puncture to revascularization measured in minutes. Lower values indicate shorter time to revascularization and vice versa. | 939 patients were analyzed | Posted | Mean | Standard Deviation | minutes | Day 0-At the completion of the thrombectomy procedure |
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| Other Pre-specified | Incidence of Procedure Related Serious Adverse Events | Any procedure related serious adverse events occurring upon insertion of a Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure up to 90 days post index stroke procedure. | Posted | Count of Participants | Participants | up to 90 days post index procedure |
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Up to 90 days post index stroke procedure
Per protocol SAEs were collected up to 90 days post index stroke procedure: all-cause mortality, device-related SAE associated with the use of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure and procedure related SAE occurring upon insertion of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure. Non-SAEs were not required to be collected per protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adverse Events | Serious adverse events reported per protocol during the study | 142 | 984 | 19 | 984 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cartotid Artery Dissection | Nervous system disorders | Non-systematic Assessment | Study device-related SAE |
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| Subarachnoid haemorrhage | Nervous system disorders | Non-systematic Assessment | Study device-related SAE |
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| Arteriovenous fistula | Vascular disorders | Non-systematic Assessment | Index procedure-related SAE |
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| Carotid artery dissection | Nervous system disorders | Non-systematic Assessment | Index procedure-related SAE |
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| Cerebral haemorrhage | Nervous system disorders | Non-systematic Assessment | Index procedure-related SAE |
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| Femoral artery dissection | Vascular disorders | Non-systematic Assessment | Index procedure-related SAE |
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| Headache | Nervous system disorders | Non-systematic Assessment | Index procedure-related SAE |
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| Hypotension | Vascular disorders | Non-systematic Assessment | Index procedure-related SAE |
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| Neurological decompensation | Nervous system disorders | Non-systematic Assessment | Index procedure-related SAE |
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| Peripheral artery thrombosis | Vascular disorders | Non-systematic Assessment | Index procedure-related SAE |
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| Peripheral vascular disorder | Vascular disorders | Non-systematic Assessment | Index procedure-related SAE |
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| Stroke in evolution | Nervous system disorders | Non-systematic Assessment | Index procedure-related SAE |
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| Subarachnoid haemorrhage | Nervous system disorders | Non-systematic Assessment | Index procedure-related SAE |
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| Unresponsive to stimuli | Nervous system disorders | Non-systematic Assessment | Index procedure-related SAE |
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| Vasospasm | Vascular disorders | Non-systematic Assessment | Index procedure-related SAE |
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| Vessel perforation | Vascular disorders | Non-systematic Assessment | Index procedure-related SAE |
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Researchers may Publish their individual site experience, but Sponsor reserves the exclusive right to Publish (or coordinate the Publication of) the complete accumulated results of the Registry, and to establish authorship criteria for such Publications for the Registry group based on Registry conduct and compliance, contribution to the Registry's design, management or enrollment and willingness to accept the rights and responsibilities of an author.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Oscar Bolanos | Medtronic | 949-527-0822 | Oscar.bolanos@medtronic.com |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| 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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