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Completed

NCT Number: NCT02239640

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Banner University Medical Center, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  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.

    • - No significant disability. Able to carry out all usual activities, despite some symptoms.
    • - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    • - Moderate disability. Requires some help, but able to walk unassisted.
    • - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    • - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
    • - 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.

Sponsors and collaborators

Lead sponsor

Medtronic Neurovascular Clinical Affairs

Industry

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 15, 2014
Registry last updated
Jun 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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