Prospective, Single-arm, Multi-centre Study to Evaluate the Efficacy and Safety of the iNstroke 4F Thromboaspiration Catheter in Patients with Acute Ischaemic Stroke due to Primary Distal Medium Vessel Occlusions.
Subjects aged ≥ 18 years.
Subjects with symptom onset up to 24 hours.
Isolated primary demonstrated occlusion in a distal medium vessel (Non-dominant or distal M2-MCA segment, M3 or M4 segments of MCA, A2-A3 segments of ACA, P1, P2 and P3 segments of PCA) identified by magnetic resonance angiography (MRA) or computed tomography angiography (CTA).
Baseline NIHSS score ≥5 assessed before the procedure.
Subjects aged < 18.
Suspected secondary DMVO. Suspicion or evidence of primary LVO whether it has been treated or not with fibrinolytic therapy or mechanical thrombectomy that subsequently develops a DMVO.
Baseline NIHSS score <5 assessed before the procedure.
Pre-stroke mRS score >2.
Single group
Thromboaspiration catheter
DevicePatients to undergo thromboaspiration with iNstroke 4F
Recanalization Endpoint
Recanalization rate with a modified thrombolysis in cerebral infarction scale (mTICI) score ≥2b in ≤3 revascularization passes using iNstroke 4F aspiration catheter, alone or in conjunction with a SR.
Recanalization Endpoint
Proportion of subjects treated with iNstroke 4F alone with complete recanalization in primary DMVO defined as an mTICI ≥2b, after iNstroke 4F aspiration catheter alone (ADAPT) was used as a first-line therapy
Recanalization Endpoint
Proportion of subjects treated with iNstroke 4F in conjunction with a stent retriever having complete recanalization in primary DMVO defined as achieving an mTICI ≥2b, after iNstroke 4F aspiration catheter, in conjunction with a stent retriever (SR), was used as a first-line therapy.
Recanalization Endpoint
Proportion of subjects with mTICI≥2b, mTICI≥2c and mTICI 3 after first pass with iNstroke 4F aspiration catheter used both alone and in conjunction with a SR.
Recanalization Endpoint
Time from groin puncture to achievement of complete recanalization (mTICI ≥2b), or if not achieved, until the final angiogram time, in patients treated with iNstroke 4F aspiration catheter, alone or in conjunction with a SR, as a first-line therapy.
Exploratory Recanalization Endpoint
Proportion of subjects in which a switch of technique (from ADAPT to combined or from combined to ADAPT) with iNstroke 4F aspiration catheter was used to successfully perform the thrombectomy.
Exploratory Recanalization Endpoint
Proportion of subjects in which an aspiration catheter device with a 4F caliber different from iNstroke 4F aspiration catheter was used as a rescue therapy.
Exploratory Recanalization Endpoint
Proportion of cases in which iNstroke 4F aspiration catheter (alone or in conjunction with a SR) successfully reached the site of occlusion.
Exploratory Recanalization Endpoint
Number of passes with iNstroke 4F aspiration catheter until recanalization.
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