Not yet recruiting NCT07089355
Study Evaluating Toro 88 Super Bore Aspiration Catheter for Acute Ischemic Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Toro 88 Super Bore Aspiration Catheter.
- Who it may be relevant to
- Registry conditions: Acute Ischemic Stroke. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
- Device Toro 88 Super Bore Aspiration Catheter
The Toro 88 Super Bore Aspiration Catheter is a neurovascular device designed for clot aspiration during mechanical thrombectomy procedures.
Primary outcome measures
- 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]
Secondary outcome measures (10)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- Hôpital Fondation Adolphe de Rothschild — Paris
Identifiers
NCT: NCT07089355 · P_RBC_2025_1