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Completed

NCT Number: NCT02040259

Trevo® Retriever Registry Post Market Surveillance

The purpose of the Trevo® Retriever Registry is to collect real world performance data of the Trevo Retriever which is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.

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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

Toronto Western Hospital, Toronto, Canada

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About this study

Trevo Retriever Registry is a prospective, open-label, consecutive enrollment, multi-center, international registry that may enroll a maximum of 2000 patients at up to 100 sites worldwide. Revascularization status will be assessed at the end of the procedure using the modified TICI (Thrombolysis in Cerebral Infarction)score. Additional data collection will include:

  • Day 90 mRS assessment
  • Day 90 all cause mortality
  • Neurological deterioration at 24 hours post procedure, defined as a four or more point increase in the NIHSS score from the baseline score
  • Rates of device and procedure related serious adverse events (AEs)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects experiencing acute ischemic stroke who are eligible for restoration of blood flow using any approved Trevo Retriever in the neurovasculature to remove thrombus
  • Trevo Retriever is the initial mechanical neuro-thrombectomy device used to remove the thrombus
  • Signed Informed Consent obtained
  • Subject willing to comply with the protocol follow-up requirements
  • Anticipated life expectancy of at least 3 months

Exclusion criteria

  • The subject is participating in another mechanical neuro-thrombectomy device trial or any other clinical trial where the study procedure or treatment might confound the study end point.

Treatment and study plan

Primary outcomes

  1. Revascularization Status Assessment at the End of the Trevo Retriever Procedure Using the Modified TICI Score

    Time frame: Post Procedure

    The primary end point is revascularization based on modified Thrombolysis in Cerebral Infarction score (mTICI). Per protocol, successful revascularization is defined as having a modified TICI score ≥2b at the end of the procedure.

    Modified TICI Scale (mTICI Scale) Grade 0 - No Perfusion Grade 1 - Penetration with Minimal Perfusion Grade 2 - Partial Perfusion Grade 2a - Only partial filling (< 50%) of the entire vascular territory is visualized.

    Grade 2b - Filling of > 50% all of the expected vascular territory is visualized, but the filling is slower than normal.

    Grade 3 - Complete Perfusion

Secondary outcomes

  1. Modified Rankin Scale (mRS) Assessment at 90 Days

    Time frame: 90 days

    The Modified Rankin Scale mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.

    A good clinical outcome = mRS scale 0-2. 0 - No symptoms at all.

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

  2. All Cause Mortality

    Time frame: 90 days

    Overall mortality rate

  3. Device and Procedure Related Serious Adverse Events (SAEs)

    Time frame: 90 days

    Rate of Device and Procedure related serious adverse events (SAE)

  4. Neurological Deterioration at 24 Hours

    Time frame: 24 hours

    Neurological Deterioration at 24 hours post procedure, defined as a 4 point or more increase in the NIHSS score over the baseline score.

Sponsors and collaborators

Lead sponsor

Stryker Neurovascular

Industry

Registry information

Official study title

Stryker Neurovascular Trevo® Retriever Registry

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jan 20, 2014
Registry last updated
Jun 24, 2020

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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