REVascularization In Large VEssel Occlusion for Acute Ischemic Stroke (NCT07216170) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
REVascularization In Large VEssel Occlusion for Acute Ischemic Stroke
200 participantsStarted 2026-12
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. Independent status immediately pre-stroke defined as ability to perform all activities of daily living as defined by mRS 0-1
. Large vessel occlusion of the intracranial internal carotid artery (ICA), middle cerebral artery (MCA) M1 segment technically accessible, as assessed during the index procedure, using a SOFIA Flow 88 Aspiration Catheter
. Subject or legally authorized representative (LAR) is willing and able to provide informed consent, as evidenced by signing and dating the IRB-approved informed consent form prior to initiation of any study-specific procedures
. Willing and able to comply with the protocol-specified procedures and assessments
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is focused on revascularization — meaning physically reopening a blocked blood vessel — in large vessel occlusion stroke, is my stroke caused by that type of large vessel blockage, and would that make this trial worth discussing as an option for me?
2One of the main things this trial is measuring is symptomatic intracranial hemorrhage — bleeding in the brain — as a safety outcome. What does that risk look like compared to the standard treatment I would receive if I didn't participate?
3This trial hasn't started recruiting yet — given how time-sensitive stroke treatment is, what are my best available options right now, and is it worth waiting or inquiring about this study's timeline?
4The trial is listed as Phase NA, which can sometimes mean it involves a procedure or device rather than a drug. Can you explain exactly what the revascularization approach being studied here involves, and how it differs from what's currently standard of care for large vessel occlusion stroke?
5Since the trial is also measuring reperfusion success — whether blood flow is actually restored — how would doctors know during or after the procedure whether it worked, and what happens next if it doesn't succeed?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of all symptomatic intracranial hemorrhage (sICH)
. 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)
. Clinical symptoms or non-invasive imaging suggestive of or confirming bilateral stroke or stroke in multiple territories defined as multiple large vessel occlusions (e.g., bilateral proximal MCA occlusions)
. Comorbid illness that would confound the neurological or functional evaluation or is severe enough (e.g., metastatic cancer, severe congestive heart failure) such that life expectancy is \<1 year or the 90-day outcome is likely to be determined by the comorbid illness
. Any contraindication to endovascular thrombectomy, such as a known history of severe contrast allergy or absolute contraindication to iodinated contrast
. Participation in another clinical trial involving an investigational mechanical device (subjects may be co-enrolled in a registry study where there is no investigational treatment).