Systematic Evaluation of Patients Treated With Stroke Devices for Acute Ischemic Stroke (STRATIS) Registry
- Conditions
- Ischemic Stroke
- Registration Number
- NCT02239640
- Lead Sponsor
- Medtronic Neurovascular Clinical Affairs
- Brief Summary
The purpose of this registry is to assess clinical outcomes, and different factors that may affect these clinical outcomes such as systems of care, associated with the use of Covidien market-released neurothrombectomy devices intended to restore blood flow in patients experiencing acute ischemic stroke due to large intracranial vessel occlusion.
- Detailed Description
This is a prospective, multi-center, non-randomized, observational registry of acute ischemic stroke patients that have or will undergo treatment with the use of a Covidien market-released neurothrombectomy device (as the initial device used to remove the thrombus) within 8 hours of stroke symptom onset, at the discretion of the investigator and independent of participation in this registry. This registry may enroll up to 1000 patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 984
- Patient or patient's legally authorized representative has given Informed Consent according to Good Clinical Practices (GCP) and/or IRB and/or local or institutional policies.
- Patient has experienced an acute ischemic stroke due to large intracranial vessel occlusion (with associated symptoms) and has been or will be treated with a Covidien market-released neurothrombectomy device, as the initial device used to remove the thrombus.
- Treatment within 8 hours of stroke onset.
- Pre-Stroke Modified Rankin Scale (mRS) score ≤ 1 (immediately) prior to stroke onset.
- Pre-treatment National Institutes of Health Stroke Scale (NIHSS) ≥ 8 and ≤ 30.
- Concurrent participation in a multicenter randomized study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants Assessed for Revascularization With mTICI Grades 2b-3 Day 0-At the completion of the thrombectomy procedure Assess revascularization using modified Thrombolysis in Cerebral Infarction (mTICI) score at the end of the procedure. This scale determines the response of therapy for ischemic stroke based on angiographic appearances of the treated occluded vessel and the distal branches.
Classification:
grade 0: no perfusion grade 1: antegrade reperfusion past the initial occlusion, but limited distal branch filling with little or slow distal reperfusion grade 2a: antegrade reperfusion of less than half of the occluded target artery previously ischemic territory grade 2b: antegrade reperfusion of more than half of the previously occluded target artery ischemic territory grade 3: complete antegrade reperfusion of the previously occluded target artery ischemic territory, with absence of visualized occlusion in all distal branches (higher values represent better outcomes)
- Secondary Outcome Measures
Name Time Method Incidence of Neurological Events of Interest up to 90 days post index procedure Evaluate events causing neurological deterioration (defined as ≥ 4 worsening points from baseline on the NIHSS scale)
Trial Locations
- Locations (55)
Grady Memorial Hospital
🇺🇸Atlanta, Georgia, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
OhioHealth Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
University of Arizona Medical Center
🇺🇸Tucson, Arizona, United States
University of California Los Angeles
🇺🇸Los Angeles, California, United States
Los Robles Medical Center
🇺🇸Thousand Oaks, California, United States
South Broward Hospital
🇺🇸Hollywood, Florida, United States
University of Kentucky Hospital
🇺🇸Lexington, Kentucky, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
McLaren Flint
🇺🇸Flint, Michigan, United States
St. Dominic's - Jackson Memorial Hospital
🇺🇸Jackson, Mississippi, United States
University of California Irvine
🇺🇸Irvine, California, United States
WellStar Kennestone Regional Medical Center
🇺🇸Marietta, Georgia, United States
Erlanger Medical Center
🇺🇸Chattanooga, Tennessee, United States
Baptist Health Lexington/Central Baptist
🇺🇸Lexington, Kentucky, United States
Buffalo General Medical Center
🇺🇸Buffalo, New York, United States
Advocate Christ Medical Center
🇺🇸Oak Lawn, Illinois, United States
Baptist Medical Center - Jacksonville
🇺🇸Jacksonville, Florida, United States
Crouse Hospital
🇺🇸Syracuse, New York, United States
Geisinger Clinic
🇺🇸Danville, Pennsylvania, United States
West Virginia University/ Ruby Memorial
🇺🇸Morgantown, West Virginia, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Barnes Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Albany Medical Center
🇺🇸Albany, New York, United States
University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Memorial Hermann Texas Medical Center
🇺🇸Houston, Texas, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Methodist Hospital, Houston
🇺🇸Houston, Texas, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Banner University Medical Center
🇺🇸Phoenix, Arizona, United States
Advanced Neuroscience Network/Tenet South Florida
🇺🇸Delray Beach, Florida, United States
University of Miami Hospital
🇺🇸Miami, Florida, United States
Presence St. Joseph Medical Center
🇺🇸Joliet, Illinois, United States
St. John Providence Hospital, Detroit
🇺🇸Detroit, Michigan, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
ProMedica Toledo Hospital
🇺🇸Toledo, Ohio, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
Oregon Health and Science University Hospital
🇺🇸Portland, Oregon, United States
Aurora Hospital, Milwaukee
🇺🇸Milwaukee, Wisconsin, United States
Mayo Clinic, Rochester
🇺🇸Rochester, Minnesota, United States
Froedtert Hospital
🇺🇸Milwaukee, Wisconsin, United States
Valley Baptist Medical Center
🇺🇸Harlingen, Texas, United States
Baptist Hospital Louisville
🇺🇸Louisville, Kentucky, United States
St. Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
Mercy San Juan Medical Center/ Mercy General
🇺🇸Sacramento, California, United States
Florida Hospital
🇺🇸Orlando, Florida, United States
Norton Healthcare
🇺🇸Louisville, Kentucky, United States