Acute Ischemic Stroke
Conditions
Keywords
Stroke, Mechanical Thrombectomy, Acute Ischemic Stroke
Brief 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.
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.
Interventions
DEVICEToro 88 Super Bore Aspiration Catheter
The Toro 88 Super Bore Aspiration Catheter is a neurovascular device designed for clot aspiration during mechanical thrombectomy procedures.
Sponsors
Toro Neurovascular, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events that may be associated with the use of the experimental device at 24-36h | From start of procedure to 24-36 hours post-procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lesion site reached according to the operator | Intra-procedural | — |
| eTICI score ≥ 2c after the first pass with the experimental device | Immediately after first device pass (intra-procedural) | — |
| eTICI score ≥ 2b67 after the first pass with the experimental device | Immediately after first device pass (intra-procedural) | — |
| Symptomatic intracranial haemorrhage | 22 to 36 hours after reperfusion | 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. |
| eTICI score ≥ 2b50 after a maximum of 3 passages with the experimental device | Immediately after final device pass (intra-procedural) | — |
| NIHSS score | At discharge and at 90 days post-procedure | — |
| All serious adverse events | From procedure to 90 days post-procedure | — |
| All-cause death | From procedure to 90 days post-procedure | — |
| Modified Rankin Score (mRS) ≤ 2 | At 90 days post-procedure | — |
| All adverse events | From procedure to 90 days post-procedure | — |
Countries
France
Contacts
Primary ContactCheffe de Service
Outcome results
None listed