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

NCT02239640 | Completed Results

• 1 other identifier: NV-SFR005
• Study Type: observational
• Target: 984
• Locations: 1 country
• Sites: 55

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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Incidence of Neurological Events of Interest

  up to 90 days post index procedure

Other Outcomes (5)

• All-cause Mortality

  up to 90 days post index procedure

• Number of Participants With Good Functional Outcome (mRS 0-2)

  90 days post index procedure

• Incidence of Device Related Serious Adverse Events

  up to 90 days post index procedure

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acute Ischemic Stroke Patients

You may qualify if:

• 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.

You may not qualify if:

• Concurrent participation in a multicenter randomized study.

Sponsors & Collaborators

• Medtronic Neurovascular Clinical Affairs: lead

Study Sites (55)

Banner University Medical Center

Phoenix, Arizona, 85006, United States

Location

University of Arizona Medical Center

Tucson, Arizona, 85724, United States

Location

University of California Irvine

Irvine, California, 92697, United States

Location

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Mercy San Juan Medical Center/ Mercy General

Sacramento, California, 95816, United States

Location

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

Los Robles Medical Center

Thousand Oaks, California, 91360, United States

Location

Advanced Neuroscience Network/Tenet South Florida

Delray Beach, Florida, 33484, United States

Location

South Broward Hospital

Hollywood, Florida, 33021, United States

Location

Baptist Medical Center - Jacksonville

Jacksonville, Florida, 32207, United States

Location

University of Miami Hospital

Miami, Florida, 33136, United States

Location

Baptist Hospital of Miami

Miami, Florida, 33176, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

WellStar Kennestone Regional Medical Center

Marietta, Georgia, 30060, United States

Location

Presence St. Joseph Medical Center

Joliet, Illinois, 60435, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

Baptist Health Lexington/Central Baptist

Lexington, Kentucky, 40503, United States

Location

University of Kentucky Hospital

Lexington, Kentucky, 40536, United States

Location

Baptist Hospital Louisville

Louisville, Kentucky, 40207, United States

Location

Norton Healthcare

Louisville, Kentucky, 40241, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

St. John Providence Hospital, Detroit

Detroit, Michigan, 48236, United States

Location

McLaren Flint

Flint, Michigan, 48532, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic, Rochester

Rochester, Minnesota, 55905, United States

Location

St. Dominic's - Jackson Memorial Hospital

Jackson, Mississippi, 39216, United States

Location

St. Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Buffalo General Medical Center

Buffalo, New York, 14203, United States

Location

Crouse Hospital

Syracuse, New York, 13210, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28207, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

OhioHealth Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Oregon Health and Science University Hospital

Portland, Oregon, 97239, United States

Location

Geisinger Clinic

Danville, Pennsylvania, 17822, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Erlanger Medical Center

Chattanooga, Tennessee, 37403, United States

Location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Valley Baptist Medical Center

Harlingen, Texas, 78550, United States

Location

Memorial Hermann Texas Medical Center

Houston, Texas, 77030, United States

Location

Methodist Hospital, Houston

Houston, Texas, 77030, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98111, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

West Virginia University/ Ruby Memorial

Morgantown, West Virginia, 26506, United States

Location

Aurora Hospital, Milwaukee

Milwaukee, Wisconsin, 53215, United States

Location

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (8)

• 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.

  PMID: 34504469 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.

  PMID: 34311566 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.

  PMID: 34078106 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.

  PMID: 32385089 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.

  PMID: 30776994 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.

  PMID: 30626287 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.

  PMID: 28943516 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.

  PMID: 28830971 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Oscar Bolanos
• Organization: Medtronic

Oscar.bolanos@medtronic.com

949-527-0822

Study Officials

• Nils Mueller-Kronast, M.D.

  Advanced Neuroscience Network/Tenet South Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2014
• First Posted: September 15, 2014
• Study Start: August 21, 2014
• Primary Completion: October 7, 2016
• Study Completion: October 7, 2016
• Last Updated: June 7, 2019
• Results First Posted: June 7, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (55)