Tigertriever is a CE marked mechanical revascularization device indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment. The objective of the TIGER Study is to evaluate the safety and effectiveness of the Tigertriever device in restoring blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke due to a large vessel occlusion (LVO). This study is designed to support substantial equivalence to approved and marketed products such as the Solitaire or Trevo Retriever.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Mechanical Thrombectomy
UCLA medical center
Los Angeles, California, United States
Los Robles
Thousand Oaks, California, United States
Tenet Health
Coral Springs, Florida, United States
Baptist Health Research Institute
Jacksonville, Florida, United States
Baptist Health South Florida
Miami, Florida, United States
University of Miami
Miami, Florida, United States
WellStar Research Institute
Marietta, Georgia, United States
University of Iowa
Iowa City, Iowa, United States
University of Massachusetts
Worcester, Massachusetts, United States
Maimonides Medical Center
Brooklyn, New York, United States
...and 7 more locations
Successful Reperfusion, Defined as mTICI Score ≥ 2b
Effectiveness (Successful reperfusion)
Time frame: Day 0 (end of procedure)
All-cause Mortality
Safety (All-cause mortality)
Time frame: 90 days post treatment
Symptomatic Intracranial Hemorrhage (sICH) Defined as Any Parenchymal Hematoma Type 2, Remote Intracerebral Hemorrhage, Subarachnoid Hemorrhage, or Intraventricular Hemorrhage That is the Predominant Cause of ≥4 Point NIHSS Deterioration at 24 Hours
Safety (Symptomatic intracranial hemorrhage (sICH)) defined as any parenchymal hematoma type 2, remote intracerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage that is the predominant cause of ≥4 point NIHSS deterioration at 24 hours.
Time frame: 24 hours post procedure
Modified Rankin Scale (mRS) Score of ≤2
modified Ranking Scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death.
Time frame: 90 days post treatment
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