Acute Ischemic StrokeTORO EFFECT FRNCT07089355
Study Evaluating Toro 88 Super Bore Aspiration Catheter for Acute Ischemic Stroke
A study testing Toro 88 Super Bore Aspiration Catheter in people with Acute Ischemic Stroke, run by Toro Neurovascular, Inc. at 1 site in France.
Trial summary
The goal of this pilot study is to evaluate the safety and efficacy of the Toro 88 Super Bore Aspiration Catheter in acute ischemic stroke patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Toro 88 Super Bore Aspiration Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2025to Mar 2026
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥ 18 and ≤ 90 years at the time of consent
- Presenting with an acute ischaemic stroke for which symptoms (or last time seen as normal) are < 24h
- With occlusion of the ICA / the M1 segment of the MCA / a vertebral artery diameter ≥3.5mm / the basilar artery, defined by eTICI≤1
- Requiring endovascular treatment (mechanical thrombectomy) with or without intravenous thrombolysis
- For whom the experimental device is the first-line treatment
- Without pre-existing disability (mRS ≤3 and 6≤ NIHSS ≤30 before stroke)
Show all 9Show fewer
- Informed consent signed :
- By the patient
- Or consent by a family member/trusted support person if the patient's condition does not allow them to express their consent in writing (L1111-6)
Who cannot join
- Arterial dissection
- Suspicion of vasculitis
- Suspected intracranial stenosis near the occlusion site
- Concomitant intracranial haemorrhage
- Known coagulation disorder
- Known coagulopathy
Show all 19Show fewer
- Known platelet count <50,000/μL
- Significant mass effect with midline shift
- Suspicion or evidence of aortic dissection, septic embolus, or bacterial endocarditis
- INR ≥ 3.0
- APTT ≥ 2 times normal
- Systolic blood pressure > 185 mmHg and/or diastolic blood pressure < 110 mmHg
- Blood glucose < 50 mg/dL or >400 mg/dL according to the last measurement taken before the procedure
- Known allergy to contrast media
- Occluded arteries in more than one large vascular territory (at least two of the left and right internal carotid arteries or the territory of a carotid artery and an artery of the vertebrobasilar system).
- Pregnant or breast-feeding women (urine or serum pregnancy test negative at inclusion).
- Adults under legal protection (L1121-8)
- Persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care under articles L3212-1 and L3123-1 and persons admitted to a health or social establishment for purposes other than research (L1121-6).
- Participation in other interventional clinical research
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Fondation Adolphe de Rothschild
Paris, 75019
Cheffe de Service, +33 1 48 03 64 54, ayavchitz@for.paris
About this study
Official title: Open-Label, Single-Arm Study Evaluating Toro 88 Super Bore Aspiration Catheter Safety and Efficacy in Mechanical Thrombectomy for Acute Ischemic Stroke in France
The goal of this pilot study is to evaluate the safety and efficacy of the Toro 88 Super Bore Aspiration Catheter in acute ischemic stroke patients.
Read the detailed description
This is a prospective, open-label, single-arm, single-center clinical investigation evaluating the safety and efficacy of the Toro 88 Super Bore Aspiration Catheter in mechanical thrombectomy for acute ischemic stroke. The study is being conducted at the Hôpital Fondation Adolphe de Rothschild in France.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Toro 88 Super Bore Aspiration Catheter
- Keywords
- Stroke, Mechanical Thrombectomy, Acute Ischemic Stroke
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toro 88 Super Bore Aspiration CatheterDevice
The Toro 88 Super Bore Aspiration Catheter is a neurovascular device designed for clot aspiration during mechanical thrombectomy procedures.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Participants with acute ischemic stroke will undergo mechanical thrombectomy using the Toro 88 Super Bore Aspiration Catheter as first-line treatment. Receives: Device: Toro 88 Super Bore Aspiration Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events that may be associated with the use of the experimental device at 24-36h
Measured: From start of procedure to 24-36 hours post-procedure
Secondary outcomes (10)
eTICI score ≥ 2b50 after a maximum of 3 passages with the experimental device
Measured: Immediately after final device pass (intra-procedural)
Lesion site reached according to the operator
Measured: Intra-procedural
eTICI score ≥ 2c after the first pass with the experimental device
Measured: Immediately after first device pass (intra-procedural)
eTICI score ≥ 2b67 after the first pass with the experimental device
Measured: Immediately after first device pass (intra-procedural)
Symptomatic intracranial haemorrhage
Symptomatic intracranial haemorrhage according to the SITS-MOST definition (Lancet 2007) : occurrence of an intraparenchymal haematoma (PH-2) on imaging, within 22-36 hours after reperfusion treatment, associated with a clinical worsening defined by a worsening of at least 4 NIHSS points.
Measured: 22 to 36 hours after reperfusion
All adverse events
Measured: From procedure to 90 days post-procedure
NIHSS score
Measured: At discharge and at 90 days post-procedure
All serious adverse events
Measured: From procedure to 90 days post-procedure
All-cause death
Measured: From procedure to 90 days post-procedure
Modified Rankin Score (mRS) ≤ 2
Measured: At 90 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toro Neurovascular, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089355
- Sponsor's protocol ID
- P_RBC_2025_1
- Acronym
- TORO EFFECT FR
- Status last verified
- Jul 2025
- First submitted
- 20 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Single-Arm Study Evaluating Toro 88 Super Bore Aspiration Catheter Safety and Efficacy in Mechanical Thrombectomy for Acute Ischemic Stroke in France
- ClinicalTrials.gov ID
- NCT07089355
- Acronym / sponsor ID
- TORO EFFECT FR / P_RBC_2025_1
- Conditions
- Acute Ischemic Stroke
- Keywords
- Stroke, Mechanical Thrombectomy, Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Toro Neurovascular, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 28 Jul 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 goal of this pilot study is to evaluate the safety and efficacy of the Toro 88 Super Bore Aspiration Catheter in acute ischemic stroke patients.
Detailed description
This is a prospective, open-label, single-arm, single-center clinical investigation evaluating the safety and efficacy of the Toro 88 Super Bore Aspiration Catheter in mechanical thrombectomy for acute ischemic stroke. The study is being conducted at the Hôpital Fondation Adolphe de Rothschild in France.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: Toro 88 Super Bore Aspiration CatheterParticipants with acute ischemic stroke will undergo mechanical thrombectomy using the Toro 88 Super Bore Aspiration Catheter as first-line treatment. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients aged ≥ 18 and ≤ 90 years at the time of consent
- Presenting with an acute ischaemic stroke for which symptoms (or last time seen as normal) are < 24h
- With occlusion of the ICA / the M1 segment of the MCA / a vertebral artery diameter ≥3.5mm / the basilar artery, defined by eTICI≤1
- Requiring endovascular treatment (mechanical thrombectomy) with or without intravenous thrombolysis
- For whom the experimental device is the first-line treatment
Key exclusion criteria (19 listed)
- Arterial dissection
- Suspicion of vasculitis
- Suspected intracranial stenosis near the occlusion site
- Concomitant intracranial haemorrhage
- Known coagulation disorder
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 |
|---|---|---|
| Toro 88 Super Bore Aspiration CatheterThe Toro 88 Super Bore Aspiration Catheter is a neurovascular device designed for clot aspiration during mechanical thrombectomy procedures. | Device | Treatment Arm |
Primary outcome
Incidence of adverse events that may be associated with the use of the experimental device at 24-36h
Time frame: From start of procedure to 24-36 hours post-procedure
10 secondary outcomes
eTICI score ≥ 2b50 after a maximum of 3 passages with the experimental device
Time frame: Immediately after final device pass (intra-procedural)
Lesion site reached according to the operator
Time frame: Intra-procedural
eTICI score ≥ 2c after the first pass with the experimental device
Time frame: Immediately after first device pass (intra-procedural)
eTICI score ≥ 2b67 after the first pass with the experimental device
Time frame: Immediately after first device pass (intra-procedural)
Symptomatic intracranial haemorrhage
Time frame: 22 to 36 hours after reperfusion
All adverse events
Time frame: From procedure to 90 days post-procedure
NIHSS score
Time frame: At discharge and at 90 days post-procedure
All serious adverse events
Time frame: From procedure to 90 days post-procedure
All-cause death
Time frame: From procedure to 90 days post-procedure
Modified Rankin Score (mRS) ≤ 2
Time frame: At 90 days post-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 28 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Acute Ischemic Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
Not yet recruitingPhase 3
INTRA-ARTERIAL MeVO TREATMENT (IMP-ACT) Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632
Stroke, Acute Ischemic, Medium Vessel Occlusion
Not yet recruitingPhase 2/3
A Phase II/III Clinical Study of SIM0811 in the Treatment of Acute Ischemic Stroke
Acute Ischemic Stroke AIS
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toro 88 Super Bore Aspiration Catheter in people with Acute Ischemic Stroke, run by Toro Neurovascular, Inc. at 1 site in France.
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 9 inclusion and 19 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 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Cheffe de Service (+33 01 48 03 64 54, ayavchitz@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events that may be associated with the use of the experimental device at 24-36h (time frame: From start of procedure to 24-36 hours post-procedure). 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 28 Jul 2025.