NCT07089355Not yet recruiting
Study Evaluating Toro 88 Super Bore Aspiration Catheter for Acute Ischemic Stroke
Open-Label, Single-Arm Study Evaluating Toro 88 Super Bore Aspiration Catheter Safety and Efficacy in Mechanical Thrombectomy for Acute Ischemic Stroke in France
Source: ClinicalTrials.gov · Last updated 28 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 20 Jul 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Toro Neurovascular, Inc.
- Diseases
- Stroke
- NCT number
- NCT07089355
What you commit to
- Study type: Interventional
- Planned participants: 15
- From 1 Jul 2025 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant intracranial haemorrhage
Other illness
- Known coagulation disorder
- Known allergy to contrast media
- 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).
Lab values
- Known platelet count \<50,000/μL
- INR ≥ 3.0
- APTT ≥ 2 times normal
- Blood glucose \< 50 mg/dL or \>400 mg/dL according to the last measurement taken before the procedure
- Pregnant or breast-feeding women (urine or serum pregnancy test negative at inclusion).
Other
- Arterial dissection
- Suspicion of vasculitis
- Suspected intracranial stenosis near the occlusion site
- Known coagulopathy
- Significant mass effect with midline shift
- Suspicion or evidence of aortic dissection, septic embolus, or bacterial endocarditis
- Systolic blood pressure \> 185 mmHg and/or diastolic blood pressure \< 110 mmHg
- 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).
- Adults under legal protection (L1121-8)
- Participation in other interventional clinical research
Who the study is looking for
- 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)
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Fondation Adolphe de Rothschild Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.