Systematic Evaluation of Patients Treated With Stroke Devices for Acute Ischemic Stroke (STRATIS) Registry

NCT ID: NCT02239640

Last Updated: 2019-06-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

984 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-21

Study Completion Date

2016-10-07

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Neurovascular Clinical Affairs

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nils Mueller-Kronast, M.D.

Role: PRINCIPAL_INVESTIGATOR

Advanced Neuroscience Network/Tenet South Florida

Locations

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Banner University Medical Center

Phoenix, Arizona, United States

Site Status

University of Arizona Medical Center

Tucson, Arizona, United States

Site Status

University of California Irvine

Irvine, California, United States

Site Status

University of California Los Angeles

Los Angeles, California, United States

Site Status

Mercy San Juan Medical Center/ Mercy General

Sacramento, California, United States

Site Status

California Pacific Medical Center

San Francisco, California, United States

Site Status

Los Robles Medical Center

Thousand Oaks, California, United States

Site Status

Advanced Neuroscience Network/Tenet South Florida

Delray Beach, Florida, United States

Site Status

South Broward Hospital

Hollywood, Florida, United States

Site Status

Baptist Medical Center - Jacksonville

Jacksonville, Florida, United States

Site Status

University of Miami Hospital

Miami, Florida, United States

Site Status

Baptist Hospital of Miami

Miami, Florida, United States

Site Status

Florida Hospital

Orlando, Florida, United States

Site Status

Grady Memorial Hospital

Atlanta, Georgia, United States

Site Status

WellStar Kennestone Regional Medical Center

Marietta, Georgia, United States

Site Status

Presence St. Joseph Medical Center

Joliet, Illinois, United States

Site Status

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

Site Status

Baptist Health Lexington/Central Baptist

Lexington, Kentucky, United States

Site Status

University of Kentucky Hospital

Lexington, Kentucky, United States

Site Status

Baptist Hospital Louisville

Louisville, Kentucky, United States

Site Status

Norton Healthcare

Louisville, Kentucky, United States

Site Status

Maine Medical Center

Portland, Maine, United States

Site Status

University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, United States

Site Status

St. John Providence Hospital, Detroit

Detroit, Michigan, United States

Site Status

McLaren Flint

Flint, Michigan, United States

Site Status

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic, Rochester

Rochester, Minnesota, United States

Site Status

St. Dominic's - Jackson Memorial Hospital

Jackson, Mississippi, United States

Site Status

St. Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Site Status

Barnes Jewish Hospital

St Louis, Missouri, United States

Site Status

Albany Medical Center

Albany, New York, United States

Site Status

Buffalo General Medical Center

Buffalo, New York, United States

Site Status

Crouse Hospital

Syracuse, New York, United States

Site Status

Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

OhioHealth Riverside Methodist Hospital

Columbus, Ohio, United States

Site Status

ProMedica Toledo Hospital

Toledo, Ohio, United States

Site Status

Providence St. Vincent Medical Center

Portland, Oregon, United States

Site Status

Oregon Health and Science University Hospital

Portland, Oregon, United States

Site Status

Geisinger Clinic

Danville, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Erlanger Medical Center

Chattanooga, Tennessee, United States

Site Status

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Baylor University Medical Center

Dallas, Texas, United States

Site Status

Valley Baptist Medical Center

Harlingen, Texas, United States

Site Status

Memorial Hermann Texas Medical Center

Houston, Texas, United States

Site Status

Methodist Hospital, Houston

Houston, Texas, United States

Site Status

Virginia Mason Medical Center

Seattle, Washington, United States

Site Status

Swedish Medical Center

Seattle, Washington, United States

Site Status

West Virginia University/ Ruby Memorial

Morgantown, West Virginia, United States

Site Status

Aurora Hospital, Milwaukee

Milwaukee, Wisconsin, United States

Site Status

Froedtert Hospital

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34504469 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34311566 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34078106 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32385089 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30776994 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30626287 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28943516 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28830971 (View on PubMed)

Other Identifiers

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NV-SFR005

Identifier Type: -

Identifier Source: org_study_id

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