Clinical trial NCT02239640: Systematic Evaluation of Patients Treated With Stroke Devices for Acute Ischemic Stroke (STRATIS) Registry
Official title: Systematic Evaluation of Patients Treated With Stroke Devices for Acute Ischemic Stroke (STRATIS) Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Lead sponsor: Medtronic Neurovascular Clinical Affairs
Sponsor class: INDUSTRY
First posted: 2014-09-15
Enrollment: 984
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute Ischemic Stroke Patients

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patient or patient's legally authorized representative has given Informed Consent according to Good Clinical Practices (GCP) and/or IRB and/or local or institutional policies.
* Patient has experienced an acute ischemic stroke due to large intracranial vessel occlusion (with associated symptoms) and has been or will be treated with a Covidien market-released neurothrombectomy device, as the initial device used to remove the thrombus.
* Treatment within 8 hours of stroke onset.
* Pre-Stroke Modified Rankin Scale (mRS) score ≤ 1 (immediately) prior to stroke onset.
* Pre-treatment National Institutes of Health Stroke Scale (NIHSS) ≥ 8 and ≤ 30.

Exclusion Criteria:

* Concurrent participation in a multicenter randomized study.

Primary outcomes:
measure: Number of Participants Assessed for Revascularization With mTICI Grades 2b-3
timeFrame: Day 0-At the completion of the thrombectomy procedure
Secondary outcomes:
measure: Incidence of Neurological Events of Interest
timeFrame: up to 90 days post index procedure
Other outcomes:
measure: All-cause Mortality
timeFrame: up to 90 days post index procedure
measure: Number of Participants With Good Functional Outcome (mRS 0-2)
timeFrame: 90 days post index procedure
measure: Incidence of Device Related Serious Adverse Events
timeFrame: up to 90 days post index procedure
measure: Time to Revascularization
timeFrame: Day 0-At the completion of the thrombectomy procedure
measure: Incidence of Procedure Related Serious Adverse Events
timeFrame: up to 90 days post index procedure
Locations:
city: Phoenix
country: United States
facility: Banner University Medical Center
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Medical Center
state: Arizona
city: Irvine
country: United States
facility: University of California Irvine
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Sacramento
country: United States
facility: Mercy San Juan Medical Center/ Mercy General
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Thousand Oaks
country: United States
facility: Los Robles Medical Center
state: California
city: Delray Beach
country: United States
facility: Advanced Neuroscience Network/Tenet South Florida
state: Florida
city: Hollywood
country: United States
facility: South Broward Hospital
state: Florida
city: Jacksonville
country: United States
facility: Baptist Medical Center - Jacksonville
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Marietta
country: United States
facility: WellStar Kennestone Regional Medical Center
state: Georgia
city: Joliet
country: United States
facility: Presence St. Joseph Medical Center
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Lexington
country: United States
facility: Baptist Health Lexington/Central Baptist
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky Hospital
state: Kentucky
city: Louisville
country: United States
facility: Baptist Hospital Louisville
state: Kentucky
city: Louisville
country: United States
facility: Norton Healthcare
state: Kentucky
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: St. John Providence Hospital, Detroit
state: Michigan
city: Flint
country: United States
facility: McLaren Flint
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic, Rochester
state: Minnesota
city: Jackson
country: United States
facility: St. Dominic's - Jackson Memorial Hospital
state: Mississippi
city: Kansas City
country: United States
facility: St. Luke's Hospital of Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Buffalo
country: United States
facility: Buffalo General Medical Center
state: New York
city: Syracuse
country: United States
facility: Crouse Hospital
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Riverside Methodist Hospital
state: Ohio
city: Toledo
country: United States
facility: ProMedica Toledo Hospital
state: Ohio
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University Hospital
state: Oregon
city: Danville
country: United States
facility: Geisinger Clinic
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Chattanooga
country: United States
facility: Erlanger Medical Center
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Harlingen
country: United States
facility: Valley Baptist Medical Center
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Texas Medical Center
state: Texas
city: Houston
country: United States
facility: Methodist Hospital, Houston
state: Texas
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Morgantown
country: United States
facility: West Virginia University/ Ruby Memorial
state: West Virginia
city: Milwaukee
country: United States
facility: Aurora Hospital, Milwaukee
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert Hospital
state: Wisconsin
Study officials:
affiliation: Advanced Neuroscience Network/Tenet South Florida
name: Nils Mueller-Kronast, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.