Trevo® Retriever Registry Post Market Surveillance

June 11, 2020 updated by: Stryker Neurovascular

Stryker Neurovascular Trevo® Retriever Registry

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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:

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

Study Type

Observational

Enrollment (Actual)

2008

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Toronto, Canada, M5T 2S8
        • Toronto Western Hospital
      • Hradec Králové, Czechia, 50005
        • University hospital Hradec Králové
      • Bordeaux, France, 33000
        • CHU Bordeaux
      • Creteil, France, 94000
        • Hôpital Henri Mondor
      • Grenoble, France, 38700
        • Grenoble
      • Lille, France, 59037
        • CHU Lille
      • Limoges, France, 59037
        • Hopital Dupuytren
      • Nancy, France, 54035
        • Chu Nancy
      • Paris, France, 75013
        • La Pitie Salpetriere
      • Paris, France, 75019
        • La Fondation Ophtalmologique Adolphe de Rothschild
      • Tours, France, 37044
        • CHU de Tours
      • Augsburg, Germany, 86156
        • Klinikum Augsburg
      • Berlin, Germany, 12351
        • Vivantes Klinikum Neukölln
      • Dortmund, Germany, 44137
        • Klinikum Dortmund
      • Erlangen, Germany, 91504
        • Uniklinik Erlangen
      • Freiburg, Germany, 79106
        • Universitatsklinikum Freiburg
      • Heidelberg, Germany, 69120
        • Uniklinik Heidelberg
      • Homburg/ Saar, Germany, 66421
        • Uniklinik Homburg
      • Lubeck, Germany, 23538
        • UKSH; Lübeck
      • Mainz-GE, Germany, 55101
        • Uniklinik Mainz- Mainz
      • Budapest, Hungary, 1145
        • National Institute of Clinical Neurosciences
      • Brescia, Italy, 25123
        • Spedali Civili di Brescia
      • Genova, Italy, 16132
        • Ospedale San Martino
      • Jungni I Gu, Korea, Republic of, 700-721
        • Kyungpook National University Hospital
      • Seongnam-si, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital
      • Singapore, Singapore, 308433
        • National Neuroscience Institute,
      • Madrid, Spain, 28006
        • Hospital Universitario de La Princesa
      • Oviedo, Spain, 33006
        • Hospital Universitario Central de Asturias
      • Palma de Mallorca, Spain, 7120
        • Son Espases de Mallorca
      • San Sebastian, Spain, 20014
        • Hospital Universitario Donostia
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge
      • Aarau, Switzerland, 5000
        • Kantonsspital Aarau
      • Bangkok, Thailand, 10700
        • Siriraj Hospital
    • Arizona
      • Mesa, Arizona, United States, 85202
        • Banner Desert Medical Center
      • Phoenix, Arizona, United States, 85013
        • St. Joseph's Hospital and Medical Center - Dignity Health (BNI Phoenix)
    • California
      • Castro Valley, California, United States, 94546
        • Eden Medical Center
      • Fullerton, California, United States, 92835
        • St. Jude Medical Center
      • La Jolla, California, United States, 92037
        • Scripps Memorial Hospital
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center
      • Orange, California, United States, 92868
        • UCI Medical Center
      • San Francisco, California, United States, 94114
        • California Pacific Medical Center (CPMC)
      • San Jose, California, United States, 95124
        • Good Samaritan Hospital Regional Medical Center
      • Thousand Oaks, California, United States, 91360
        • Los Robles Hospital and Medical Center
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University / Yale-New Haven Hospital
    • Delaware
      • Newark, Delaware, United States, 19718
        • Christiana Hospital
    • Florida
      • Hollywood, Florida, United States, 33021
        • Memorial Regional Hospital
      • Jacksonville, Florida, United States, 32207
        • Baptist Medical Center - Jacksonville
      • Miami, Florida, United States, 33126
        • University of Miami (Jackson Memorial)
      • Orlando, Florida, United States, 32803
        • Florida Hospital
      • West Palm Beach, Florida, United States, 33409
        • Center for Advanced Research Excellence (St. Mary's Medical Center)
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Emory University at Grady Memorial Hospital
      • Marietta, Georgia, United States, 30060
        • Wellstar Kennestone Hospital
    • Illinois
      • Park Ridge, Illinois, United States, 60068
        • Advocate Christ Lutheran Hospital
      • Peoria, Illinois, United States, 61637
        • Peoria Radiology Research & Education Foundation
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • UMass Memorial
    • Michigan
      • Flint, Michigan, United States, 48532
        • McLaren Flint Regional Medical Center
      • Pontiac, Michigan, United States, 48341
        • St. Joseph Mercy
    • New Jersey
      • Trenton, New Jersey, United States, 08638
        • Capital Health System
    • New York
      • Buffalo, New York, United States, 14203
        • Buffalo General Medical Center
      • New York, New York, United States, 10029
        • Mount Sinai Health System
      • Poughkeepsie, New York, United States, 12601
        • Vassar Brothers Medical Center
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Mission Hospital
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Center
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital/ Ohio Health Research Institute
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Stroke Center, Oregon Health & Science University (OHSU)
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Memorial Hospital
      • Philadelphia, Pennsylvania, United States, 19107
        • Drexel University
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Presbyterian
    • Tennessee
      • Chattanooga, Tennessee, United States, 37377
        • Erlanger Hospital
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee Medical Center Knoxville
      • Memphis, Tennessee, United States, 38120
        • Methodist Healthcare - Memphis Hospitals
    • Texas
      • Harlingen, Texas, United States, 78550
        • Valley Baptist Harlingen
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
      • Houston, Texas, United States, 77030
        • Memorial Hermann Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Acute ischemic stroke patients who may be referred for mechanical thrombectomy is used to removed thrombus in the neurovasculature

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Mechanical thrombectomy, Trevo Retriever

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

Post Procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

  1. - No significant disability despite symptoms; able to carry out all usual duties and activities.
  2. - Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance.
  3. - Moderate disability; requiring some help, but able to walk without assistance.
  4. - Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance.
  5. - Severe disability; bedridden, incontinent and requiring constant nursing care and attention.
  6. - Dead.
90 days
All Cause Mortality
Time Frame: 90 days
Overall mortality rate
90 days
Device and Procedure Related Serious Adverse Events (SAEs)
Time Frame: 90 days
Rate of Device and Procedure related serious adverse events (SAE)
90 days
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.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Erol Veznedaroglu, MD, Drexel Neurosciences Institute,Philadelphia
  • Principal Investigator: Ronald Budzik, MD, Riverside Methodist Hospital/ Ohio Health Research Institute, Columbus, OH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 25, 2013

Primary Completion (Actual)

December 28, 2017

Study Completion (Actual)

December 28, 2017

Study Registration Dates

First Submitted

January 15, 2014

First Submitted That Met QC Criteria

January 16, 2014

First Posted (Estimate)

January 20, 2014

Study Record Updates

Last Update Posted (Actual)

June 24, 2020

Last Update Submitted That Met QC Criteria

June 11, 2020

Last Verified

June 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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