This study is to assess initial safety and performance data of the DAISe Thrombectomy Device for removal of thrombus during an acute ischemic stroke.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Use of the DAISe Thrombectomy Device
Angiosur - Unidad Vascular Integral
Itagüí, Antioquia, Colombia
Rate of Successful Revascularization
mTICI (Modified TICI) 2b-3 of the target vessel post-treatment with the DAISe Thrombectomy Device
Time frame: Procedure
Rate of Symptomatic Intracranial Hemorrhage
Time frame: 24 hours post-procedure
Rate of Procedure related Complications
Time frame: Through 90 day post-procedure
Occurrence of all intracranial hemorrhage
Time frame: 24 hours post-procedure
All-cause mortality
Time frame: Through Acute Hospital Discharge
Embolization to a New Vascular Territory
Time frame: Procedure
Successful Revascularization after first attempt with DAISe
mTICI (modified TICI) 2b-3 after first pass with device
Time frame: Procedure
Successful Revascularization after first attempt with DAISe
mTICI (modified TICI) 2c-3 after first pass with device
Time frame: Procedure
Successful Revascularization at end of procedure
mTICI (modified TICI) 2b-3 at the end of procedure
Time frame: Procedure
Successful Revascularization at end of procedure
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mTICI (modified TICI) 2c-3 at the end of procedure
Time frame: Procedure