Study Evaluating Toro 88 Super Bore Aspiration Catheter for Acute Ischemic Stroke

Launched by TORO NEUROVASCULAR, INC. · Jul 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medical device called the Toro 88 Super Bore Aspiration Catheter to see if it is safe and effective for treating people who have had an acute ischemic stroke. An ischemic stroke happens when a blood clot blocks blood flow to the brain. This device is designed to help remove the clot through a procedure called mechanical thrombectomy, which is done by a doctor inserting a small tube to suction out the clot and restore blood flow.

The study is looking for adults between 18 and 90 years old who have had a stroke within the last 24 hours and need this type of clot-removal treatment. To be eligible, patients should not have had serious disabilities before their stroke and must have certain types of artery blockages in the brain. If someone’s condition prevents them from giving consent, a family member or trusted person can agree on their behalf. Participants will receive the new device as the first treatment option during the procedure. It’s important to know that some people will not be able to join, such as those with certain bleeding problems, very high blood pressure, or allergies to contrast dye used during imaging tests. The study is not yet open for recruitment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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)
• * 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)
• Exclusion Criteria:
• • Arterial dissection
• • Suspicion of vasculitis
• • Suspected intracranial stenosis near the occlusion site
• • Concomitant intracranial haemorrhage
• • Known coagulation disorder
• • Known coagulopathy
• • 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