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

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ClinicalTrials.gov Identifier: NCT02239640
Recruitment Status : Completed
First Posted : September 15, 2014
Results First Posted : June 7, 2019
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs

Study Description
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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.

Condition or disease
Ischemic Stroke

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.
Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 984 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 90 Days
Official Title: Systematic Evaluation of Patients Treated With Stroke Devices for Acute Ischemic Stroke (STRATIS) Registry
Actual Study Start Date : August 21, 2014
Actual Primary Completion Date : October 7, 2016
Actual Study Completion Date : October 7, 2016
Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Assessed for Revascularization With mTICI Grades 2b-3 [ Time Frame: Day 0-At the completion of the thrombectomy procedure ]

    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)



Secondary Outcome Measures :
  1. Incidence of Neurological Events of Interest [ Time Frame: up to 90 days post index procedure ]
    Evaluate events causing neurological deterioration (defined as ≥ 4 worsening points from baseline on the NIHSS scale)


Other Outcome Measures:
  1. All-cause Mortality [ Time Frame: up to 90 days post index procedure ]
  2. Number of Participants With Good Functional Outcome (mRS 0-2) [ Time Frame: 90 days post index procedure ]

    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.

    1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
    2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    3. - Moderate disability. Requires some help, but able to walk unassisted.
    4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
    6. - Dead. (lower values represent less disability)

  3. Incidence of Device Related Serious Adverse Events [ Time Frame: up to 90 days post index procedure ]
    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.

  4. Time to Revascularization [ Time Frame: Day 0-At the completion of the thrombectomy procedure ]
    Arterial access puncture to revascularization measured in minutes. Lower values indicate shorter time to revascularization and vice versa.

  5. Incidence of Procedure Related Serious Adverse Events [ Time Frame: up to 90 days post index procedure ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Acute Ischemic Stroke Patients
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02239640


Locations
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Sponsors and Collaborators
Medtronic Neurovascular Clinical Affairs
Investigators
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Principal Investigator: Nils Mueller-Kronast, M.D. Advanced Neuroscience Network/Tenet South Florida
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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.
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.
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.

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Responsible Party: Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier: NCT02239640    
Other Study ID Numbers: NV-SFR005
First Posted: September 15, 2014    Key Record Dates
Results First Posted: June 7, 2019
Last Update Posted: June 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only multi center data will be available
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia