Trevo® Retriever Registry Post Market Surveillance
- Conditions
- Ischemic Stroke
- Registration Number
- NCT02040259
- Lead Sponsor
- Stryker Neurovascular
- Brief Summary
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.
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2008
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Revascularization Status Assessment at the End of the Trevo Retriever Procedure Using the Modified TICI Score 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 Outcome Measures
Name Time Method All Cause Mortality 90 days Overall mortality rate
Device and Procedure Related Serious Adverse Events (SAEs) 90 days Rate of Device and Procedure related serious adverse events (SAE)
Neurological Deterioration at 24 Hours 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.
Modified Rankin Scale (mRS) Assessment at 90 Days 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.
Trial Locations
- Locations (80)
UCLA Medical Center
🇺🇸Los Angeles, California, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
UPMC Presbyterian
🇺🇸Pittsburgh, Pennsylvania, United States
University of Miami (Jackson Memorial)
🇺🇸Miami, Florida, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Memorial Hermann Hospital
🇺🇸Houston, Texas, United States
California Pacific Medical Center (CPMC)
🇺🇸San Francisco, California, United States
St. Joseph's Hospital and Medical Center - Dignity Health (BNI Phoenix)
🇺🇸Phoenix, Arizona, United States
Drexel University
🇺🇸Philadelphia, Pennsylvania, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Christiana Hospital
🇺🇸Newark, Delaware, United States
National Neuroscience Institute,
🇸🇬Singapore, Singapore
Kantonsspital Aarau
🇨🇭Aarau, Switzerland
National Institute of Clinical Neurosciences
🇭🇺Budapest, Hungary
Siriraj Hospital
🇹🇭Bangkok, Thailand
Oregon Stroke Center, Oregon Health & Science University (OHSU)
🇺🇸Portland, Oregon, United States
Eden Medical Center
🇺🇸Castro Valley, California, United States
St. Jude Medical Center
🇺🇸Fullerton, California, United States
Scripps Memorial Hospital
🇺🇸La Jolla, California, United States
UCI Medical Center
🇺🇸Orange, California, United States
Los Robles Hospital and Medical Center
🇺🇸Thousand Oaks, California, United States
Good Samaritan Hospital Regional Medical Center
🇺🇸San Jose, California, United States
Memorial Regional Hospital
🇺🇸Hollywood, Florida, United States
Emory University at Grady Memorial Hospital
🇺🇸Atlanta, Georgia, United States
Baptist Medical Center - Jacksonville
🇺🇸Jacksonville, Florida, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Peoria Radiology Research & Education Foundation
🇺🇸Peoria, Illinois, United States
WellStar Kennestone Hospital
🇺🇸Marietta, Georgia, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
UMass Memorial
🇺🇸Worcester, Massachusetts, United States
McLaren Flint Regional Medical Center
🇺🇸Flint, Michigan, United States
St. Joseph Mercy
🇺🇸Pontiac, Michigan, United States
Buffalo General Medical Center
🇺🇸Buffalo, New York, United States
Capital Health System
🇺🇸Trenton, New Jersey, United States
Mount Sinai Health System
🇺🇸New York, New York, United States
Vassar Brothers Medical Center
🇺🇸Poughkeepsie, New York, United States
Mission Hospital
🇺🇸Asheville, North Carolina, United States
Riverside Methodist Hospital/ Ohio Health Research Institute
🇺🇸Columbus, Ohio, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Valley Baptist Harlingen
🇺🇸Harlingen, Texas, United States
University of Tennessee Medical Center Knoxville
🇺🇸Knoxville, Tennessee, United States
Methodist Healthcare - Memphis Hospitals
🇺🇸Memphis, Tennessee, United States
Toronto Western Hospital
🇨🇦Toronto, Canada
Hôpital Henri Mondor
🇫🇷Creteil, France
CHU Bordeaux
🇫🇷Bordeaux, France
University Hospital Hradec Králové
🇨🇿Hradec Králové, Czechia
GRENOBLE
🇫🇷Grenoble, France
Hopital Dupuytren
🇫🇷Limoges, France
CHU Lille
🇫🇷Lille, France
CHU Nancy
🇫🇷Nancy, France
La Pitié Salpêtrière
🇫🇷Paris, France
Klinikum Augsburg
🇩🇪Augsburg, Germany
La Fondation Ophtalmologique Adolphe de Rothschild
🇫🇷Paris, France
CHU de Tours
🇫🇷Tours, France
Universitätsklinikum Freiburg
🇩🇪Freiburg, Germany
Uniklinik Homburg
🇩🇪Homburg/ Saar, Germany
Vivantes Klinikum Neukölln
🇩🇪Berlin, Germany
UKSH; Lübeck
🇩🇪Lubeck, Germany
Uniklinik Mainz- Mainz
🇩🇪Mainz-GE, Germany
Klinikum Dortmund
🇩🇪Dortmund, Germany
Uniklinik Erlangen
🇩🇪Erlangen, Germany
Uniklinik Heidelberg
🇩🇪Heidelberg, Germany
Spedali Civili di Brescia
🇮🇹Brescia, Italy
Ospedale San Martino
🇮🇹Genova, Italy
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Jungni I Gu, Korea, Republic of
Hospital Universitario De La Princesa
🇪🇸Madrid, Spain
Hospital Universitari de Bellvitge
🇪🇸L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Central De Asturias
🇪🇸Oviedo, Spain
Hospital Universitario Donostia
🇪🇸San Sebastian, Spain
Son Espases de Mallorca
🇪🇸Palma de Mallorca, Spain
Banner Desert Medical Center
🇺🇸Mesa, Arizona, United States
Center for Advanced Research Excellence (St. Mary's Medical Center)
🇺🇸West Palm Beach, Florida, United States
Advocate Christ Lutheran Hospital
🇺🇸Park Ridge, Illinois, United States
Erlanger Hospital
🇺🇸Chattanooga, Tennessee, United States
Yale University / Yale-New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Florida Hospital
🇺🇸Orlando, Florida, United States