REVascularization In Large VEssel Occlusion for Acute Ischemic Stroke
ConditionAcute Ischemic Stroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMicrovention-Terumo, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
Age ≥18 years on the date of consent
National Institutes of Health Stroke Score (NIHSS) ≥6
Alberta Stroke Program Early CT Score (ASPECTS) ≥6 assessed within 120 minutes before arterial access, defined by either baseline non-contrast computed tomography (NCCT) or baseline diffusion-weighted magnetic resonance imaging (DW-MRI)
Angiographically suitable for endovascular intervention and the interventionalist estimates that arterial access can be achieved within 8 hours from time last known well
Disqualifiers
Any intracranial hemorrhage at baseline
Previous stroke within 90 days
Female who is pregnant or lactating or has a positive pregnancy test at time of admission
Arterial occlusive lesion is not technically amenable to recanalization, as assessed during the index procedure, using a SOFIA Flow 88 Aspiration Catheter (e.g., an extracranial carotid lesion prevents access, evidence of carotid dissection)
Trial design
Treatments tested in this trial
- SOFIA Flow 88 Aspiration Catheter
Treatment groups
200 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Microvention-Terumo, Inc.
Lead sponsor
Bright Research Partners
Collaborator
Source ClinicalTrials.gov