An interventional study of SOFIA Flow 88 Aspiration Catheter in Acute Ischemic Stroke, sponsored by Microvention-Terumo, Inc.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by Microvention-Terumo, Inc. (part of Terumo Corporation) · Not applicable, Interventional, and Treatment
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.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 200 is above the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Microvention-Terumo, Inc. is the lead sponsor of 32 studies on the registry; 7 are open to participants now.
First submitted after Microvention-Terumo, Inc. became part of Terumo Corporation.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: SOFIA Flow 88 Aspiration Catheter
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
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2027, 12 months later.
Of 81 industry-sponsored interventional studies with no phase under Ischemic Stroke, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 46. This study's planned 12 months is below that.
Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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