The objective of the DISTALS Study is to evaluate the safety and effectiveness of the Tigertriever 13 Revascularization Device in restoring blood flow in the neurovasculature by removing thrombus in patients presenting within 24 hours of onset with an ischemic stroke with disabling neurological deficits due to a primary distal vessel occlusion (DVO), as compared to medical management.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
168
patients presenting within 24 hours of onset with an ischemic stroke with disabling neurological deficits due to a primary distal vessel occlusion (DVO) will be treated with the Tigertriever 13 device.
Lakewood Regional Medical Center
Los Angeles, California, United States
Los Robles
Thousand Oaks, California, United States
Successful reperfusion (CTP or MR PWI*) without sICH**.
\*Successful reperfusion is defined as \>50% reduction in substantial hypoperfusion (Tmax \>4 seconds) volume between baseline and 24 ±6 hours of randomization. \*\*sICH shall be 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 ±6 hours of randomization.
Time frame: 24±6 Hours post randomization
All cause mortality at 90 days.
All cause mortality at 90 days.
Time frame: 90 days post randomization.
Any asymptomatic intracranial hemorrhage within 24±6 hours of randomization.
Any asymptomatic intracranial hemorrhage within 24±6 hours of randomization.
Time frame: 24±6 hours of randomization.
Device/procedure related serious adverse events (SAEs).
Device/procedure related serious adverse events (SAEs).
Time frame: 90 days post randomization.
Unanticipated adverse device effect (UADEs).
Unanticipated adverse device effect (UADEs).
Time frame: During procedure
Volume of penumbral tissue salvaged at 24±6 hours of randomization (CTP or MR DWI/PWI).
Volume of penumbral tissue salvaged at 24 ±6 hours of randomization (CTP or MR DWI/PWI).
Time frame: 24±6 hours post randomization.
Successful reperfusion at 24 hours, defined as >50% reduction in substantial hypoperfusion (Tmax >4 seconds) volume between baseline and 24 ±6 hours of randomization (assessed in both Treatment and Control arms).
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WellStar Research Institute
Marietta, Georgia, United States
Advocate Aurora Research Institute,
Chicago, Illinois, United States
Corewell Health (Spectrum)
Grand Rapids, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
University of Buffalo
Buffalo, New York, United States
NYU Langone Health
New York, New York, United States
Mount Sinai
New York, New York, United States
Stony Brook University
Stony Brook, New York, United States
...and 10 more locations
Successful reperfusion at 24 hours, defined as \>50% reduction in substantial hypoperfusion (Tmax \>4 seconds) volume between baseline and 24 ±6 hours of randomization (assessed in both Treatment and Control arms).
Time frame: 24±6 hours post randomization
Successful reperfusion (eTICI ≥2b50) rate in the distal occluded vessel after Tigertriever 13 mechanical thrombectomy (assessed in Treatment arm only).
Successful reperfusion (eTICI ≥2b50) rate in the distal occluded vessel after Tigertriever 13 mechanical thrombectomy (assessed in Treatment arm only).
Time frame: 24±6 hours Post procedure
modified Rankin Scale (mRS) score
Level of global disability at 90 days measured by the modified Rankin Scale (mRS) shift (tetrachotomized: 0, 1, 2, 3-6). Minimum score: 0; Maximum score: 6. Lower scores reflects a better clinical outcome, and higher scores reflects worse clinical outcome.
Time frame: 90 days post randomization
National Institutes of Health Stroke Scale (NIHSS) shift
NIHSS change from Baseline to Day 4. Minimum score: 0; Maximum score: 42. Lower scores reflects a better clinical outcome, and higher scores reflects worse clinical outcome.
Time frame: 4 days post procedure
EQ-5D score
Health-related quality of life at 90 days - EQ-5D. Minimum score: 1; Maximum score: 9. Lower scores reflects a better clinical outcome, and higher scores reflects worse clinical outcome.
Time frame: 90 days post randomization
MoCA: Montreal Cognitive Assessment
Cognitive function at 90 days. Minimum score: 0; Maximum score: 30. Higher scores reflects a better clinical outcome, and Lower scores reflects worse clinical outcome.
Time frame: 90 days post randomization