- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02040259
Trevo® Retriever Registry Post Market Surveillance
Stryker Neurovascular Trevo® Retriever Registry
Study Overview
Status
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:
- 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)
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Toronto, Canada, M5T 2S8
- Toronto Western Hospital
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Hradec Králové, Czechia, 50005
- University hospital Hradec Králové
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Bordeaux, France, 33000
- CHU Bordeaux
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Creteil, France, 94000
- Hôpital Henri Mondor
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Grenoble, France, 38700
- Grenoble
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Lille, France, 59037
- CHU Lille
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Limoges, France, 59037
- Hopital Dupuytren
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Nancy, France, 54035
- Chu Nancy
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Paris, France, 75013
- La Pitie Salpetriere
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Paris, France, 75019
- La Fondation Ophtalmologique Adolphe de Rothschild
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Tours, France, 37044
- CHU de Tours
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Augsburg, Germany, 86156
- Klinikum Augsburg
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Berlin, Germany, 12351
- Vivantes Klinikum Neukölln
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Dortmund, Germany, 44137
- Klinikum Dortmund
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Erlangen, Germany, 91504
- Uniklinik Erlangen
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Freiburg, Germany, 79106
- Universitatsklinikum Freiburg
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Heidelberg, Germany, 69120
- Uniklinik Heidelberg
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Homburg/ Saar, Germany, 66421
- Uniklinik Homburg
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Lubeck, Germany, 23538
- UKSH; Lübeck
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Mainz-GE, Germany, 55101
- Uniklinik Mainz- Mainz
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Budapest, Hungary, 1145
- National Institute of Clinical Neurosciences
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Brescia, Italy, 25123
- Spedali Civili di Brescia
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Genova, Italy, 16132
- Ospedale San Martino
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Jungni I Gu, Korea, Republic of, 700-721
- Kyungpook National University Hospital
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Seongnam-si, Korea, Republic of, 463-707
- Seoul National University Bundang Hospital
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Singapore, Singapore, 308433
- National Neuroscience Institute,
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Madrid, Spain, 28006
- Hospital Universitario de La Princesa
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Oviedo, Spain, 33006
- Hospital Universitario Central de Asturias
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Palma de Mallorca, Spain, 7120
- Son Espases de Mallorca
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San Sebastian, Spain, 20014
- Hospital Universitario Donostia
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Barcelona
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L'Hospitalet de Llobregat, Barcelona, Spain, 08907
- Hospital Universitari de Bellvitge
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Aarau, Switzerland, 5000
- Kantonsspital Aarau
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Bangkok, Thailand, 10700
- Siriraj Hospital
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Arizona
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Mesa, Arizona, United States, 85202
- Banner Desert Medical Center
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Phoenix, Arizona, United States, 85013
- St. Joseph's Hospital and Medical Center - Dignity Health (BNI Phoenix)
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California
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Castro Valley, California, United States, 94546
- Eden Medical Center
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Fullerton, California, United States, 92835
- St. Jude Medical Center
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La Jolla, California, United States, 92037
- Scripps Memorial Hospital
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Los Angeles, California, United States, 90095
- UCLA Medical Center
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Orange, California, United States, 92868
- UCI Medical Center
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San Francisco, California, United States, 94114
- California Pacific Medical Center (CPMC)
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San Jose, California, United States, 95124
- Good Samaritan Hospital Regional Medical Center
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Thousand Oaks, California, United States, 91360
- Los Robles Hospital and Medical Center
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Connecticut
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New Haven, Connecticut, United States, 06520
- Yale University / Yale-New Haven Hospital
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Delaware
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Newark, Delaware, United States, 19718
- Christiana Hospital
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Florida
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Hollywood, Florida, United States, 33021
- Memorial Regional Hospital
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Jacksonville, Florida, United States, 32207
- Baptist Medical Center - Jacksonville
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Miami, Florida, United States, 33126
- University of Miami (Jackson Memorial)
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Orlando, Florida, United States, 32803
- Florida Hospital
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West Palm Beach, Florida, United States, 33409
- Center for Advanced Research Excellence (St. Mary's Medical Center)
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Georgia
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Atlanta, Georgia, United States, 30303
- Emory University at Grady Memorial Hospital
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Marietta, Georgia, United States, 30060
- Wellstar Kennestone Hospital
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Illinois
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Park Ridge, Illinois, United States, 60068
- Advocate Christ Lutheran Hospital
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Peoria, Illinois, United States, 61637
- Peoria Radiology Research & Education Foundation
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa
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Kentucky
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Lexington, Kentucky, United States, 40536
- University of Kentucky
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Lexington, Kentucky, United States, 40503
- Baptist Health Lexington
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Maine
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Portland, Maine, United States, 04102
- Maine Medical Center
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins University
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Baltimore, Maryland, United States, 21201
- University of Maryland Medical Center
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Massachusetts
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Worcester, Massachusetts, United States, 01655
- UMass Memorial
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Michigan
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Flint, Michigan, United States, 48532
- McLaren Flint Regional Medical Center
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Pontiac, Michigan, United States, 48341
- St. Joseph Mercy
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New Jersey
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Trenton, New Jersey, United States, 08638
- Capital Health System
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New York
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Buffalo, New York, United States, 14203
- Buffalo General Medical Center
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New York, New York, United States, 10029
- Mount Sinai Health System
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Poughkeepsie, New York, United States, 12601
- Vassar Brothers Medical Center
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North Carolina
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Asheville, North Carolina, United States, 28801
- Mission Hospital
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Ohio
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Columbus, Ohio, United States, 43210
- Ohio State University Medical Center
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Columbus, Ohio, United States, 43214
- Riverside Methodist Hospital/ Ohio Health Research Institute
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Stroke Center, Oregon Health & Science University (OHSU)
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Pennsylvania
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Abington, Pennsylvania, United States, 19001
- Abington Memorial Hospital
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Philadelphia, Pennsylvania, United States, 19107
- Drexel University
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Pittsburgh, Pennsylvania, United States, 15213
- UPMC Presbyterian
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Tennessee
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Chattanooga, Tennessee, United States, 37377
- Erlanger Hospital
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Knoxville, Tennessee, United States, 37920
- University of Tennessee Medical Center Knoxville
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Memphis, Tennessee, United States, 38120
- Methodist Healthcare - Memphis Hospitals
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Texas
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Harlingen, Texas, United States, 78550
- Valley Baptist Harlingen
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Houston, Texas, United States, 77030
- Houston Methodist Hospital
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Houston, Texas, United States, 77030
- Memorial Hermann Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Mechanical thrombectomy, Trevo Retriever
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Revascularization Status Assessment at the End of the Trevo Retriever Procedure Using the Modified TICI Score
Time Frame: Post Procedure
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Modified Rankin Scale (mRS) Assessment at 90 Days
Time Frame: 90 days
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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.
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90 days
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All Cause Mortality
Time Frame: 90 days
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Overall mortality rate
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90 days
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Device and Procedure Related Serious Adverse Events (SAEs)
Time Frame: 90 days
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Rate of Device and Procedure related serious adverse events (SAE)
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90 days
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Neurological Deterioration at 24 Hours
Time Frame: 24 hours
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Neurological Deterioration at 24 hours post procedure, defined as a 4 point or more increase in the NIHSS score over the baseline score.
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24 hours
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Collaborators and Investigators
Sponsor
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- T4025
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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