The objective of this study is to evaluate the safety and effectiveness of the SOFIA Flow 88 Aspiration Catheter for treatment of acute ischemic stroke.
The investigation is a prospective, single-arm, multi-center clinical study. The study will be conducted in up to 40 investigational sites in the US, Canada, and Europe. This study will enroll up to 200 subjects, with a maximum enrollment of 30 subjects per site.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
The investigational device is the SOFIA Flow 88 Aspiration Catheter with the MV Flow Aspiration Pump and MicroVention Tubing Kit and is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 segment) within 8 hours of symptom onset.
Incidence of all symptomatic intracranial hemorrhage (sICH)
Time frame: 24 hours post-procedure
Reperfusion success
Defined as independent core laboratory adjudicated modified thrombolysis in cerebral infarction (mTICI)/expanded thrombolysis in cerebral infarction (eTICI) ≥2b flow, using the SOFIA Flow 88 Aspiration Catheter only within ≤ 3 passes and without additional intraprocedural mechanical thrombectomy devices or intra-arterial thrombolytic therapy.
Time frame: During procedure
Reperfusion success (defined as independent core laboratory adjudicated mTICI/eTICI ≥2b flow)
Time frame: During procedure
Time from arterial access to achieve mTICI/eTICI ≥2b
Time frame: During procedure
Incidence of mTICI/eTICI 3 reperfusion
Time frame: During procedure
Incidence of mTICI/eTICI ≥2c reperfusion
Time frame: During procedure
Incidence of mTICI/eTICI ≥2b reperfusion achieved with first pass of the SOFIA Flow 88 Aspiration Catheter
Time frame: During procedure
Incidence of mTICI/eTICI ≥2c reperfusion achieved with first pass of the SOFIA Flow 88 Aspiration Catheter
Time frame: During procedure
Incidence of functional independence (modified Rankin scale (mRS) ≤2)
Time frame: 90-days follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Mortality
Time frame: 90 days post-procedure
Incidence of intracranial hemorrhage (ICH)
Time frame: 24 hours post-procedure
Incidence of Embolization to New Territory
Time frame: During procedure