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.
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
2,008
Revascularization Status Assessment at the End of the Trevo Retriever Procedure Using the Modified TICI Score
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
Time frame: Post Procedure
Modified Rankin Scale (mRS) Assessment at 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.
Time frame: 90 days
All Cause Mortality
Overall mortality rate
Time frame: 90 days
Device and Procedure Related Serious Adverse Events (SAEs)
Rate of Device and Procedure related serious adverse events (SAE)
Time frame: 90 days
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Banner Desert Medical Center
Mesa, Arizona, United States
St. Joseph's Hospital and Medical Center - Dignity Health (BNI Phoenix)
Phoenix, Arizona, 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
UCLA Medical Center
Los Angeles, California, United States
UCI Medical Center
Orange, California, United States
California Pacific Medical Center (CPMC)
San Francisco, California, United States
Good Samaritan Hospital Regional Medical Center
San Jose, California, United States
Los Robles Hospital and Medical Center
Thousand Oaks, California, United States
...and 70 more locations
Neurological Deterioration at 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.
Time frame: 24 hours