Acute Ischemic StrokeREVIVENCT07216170
REVascularization In Large VEssel Occlusion for Acute Ischemic Stroke
A study testing SOFIA Flow 88 Aspiration Catheter in people with Acute Ischemic Stroke, run by Microvention-Terumo, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- SOFIA Flow 88 Aspiration Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ted Meehan contact
About this study
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.
Read the detailed description
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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- SOFIA Flow 88 Aspiration Catheter
- Keywords
- Intracranial large vessel occlusive disease, Revascularization, Large bore catheter, Mechanical thrombectomy, Aspiration, SOFIA®, Direct Aspiration
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOFIA Flow 88 Aspiration CatheterDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| SOFIA Flow 88 Aspiration Catheter | Experimental | Not described Receives: Device: SOFIA Flow 88 Aspiration Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of all symptomatic intracranial hemorrhage (sICH)
Measured: 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.
Measured: During procedure
Secondary outcomes (10)
Reperfusion success (defined as independent core laboratory adjudicated mTICI/eTICI ≥2b flow)
Measured: During procedure
Time from arterial access to achieve mTICI/eTICI ≥2b
Measured: During procedure
Incidence of mTICI/eTICI 3 reperfusion
Measured: During procedure
Incidence of mTICI/eTICI ≥2c reperfusion
Measured: During procedure
Incidence of mTICI/eTICI ≥2b reperfusion achieved with first pass of the SOFIA Flow 88 Aspiration Catheter
Measured: During procedure
Incidence of mTICI/eTICI ≥2c reperfusion achieved with first pass of the SOFIA Flow 88 Aspiration Catheter
Measured: During procedure
Incidence of functional independence (modified Rankin scale (mRS) ≤2)
Measured: 90-days follow-up
Mortality
Measured: 90 days post-procedure
Incidence of intracranial hemorrhage (ICH)
Measured: 24 hours post-procedure
Incidence of Embolization to New Territory
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Microvention-Terumo, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bright Research Partners
- Responsible party
- Sponsor
- Investigators
- Michael Hill, MD, MSc, Principal investigator, University of Calgary & Foothills Medical CentreCharles Matouk, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216170
- Sponsor's protocol ID
- TER-CL-5000
- Acronym
- REVIVE
- Status last verified
- May 2026
- First submitted
- 8 Oct 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REVascularization In Large VEssel Occlusion for Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT07216170
- Acronym / sponsor ID
- REVIVE / TER-CL-5000
- Conditions
- Acute Ischemic Stroke
- Keywords
- Intracranial large vessel occlusive disease, Revascularization, Large bore catheter, Mechanical thrombectomy, Aspiration, SOFIA®, Direct Aspiration
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Microvention-Terumo, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Bright Research Partners
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOFIA Flow 88 Aspiration Catheter | Experimental | Device: SOFIA Flow 88 Aspiration Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOFIA Flow 88 Aspiration CatheterThe 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. | Device | SOFIA Flow 88 Aspiration Catheter |
Primary outcome
Incidence of all symptomatic intracranial hemorrhage (sICH)
Time frame: 24 hours post-procedure
Reperfusion success
Time frame: During procedure
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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ted Meehan contact
Michael Hill, MD, MSc principal investigator
University of Calgary & Foothills Medical Centre
Charles Matouk, MD principal investigator
Yale University
Questions about this trial
What is this clinical trial studying?
A study testing SOFIA Flow 88 Aspiration Catheter in people with Acute Ischemic Stroke, run by Microvention-Terumo, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jason Snider (949-795-4500, jason.snider@terumo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of all symptomatic intracranial hemorrhage (sICH) (time frame: 24 hours post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.