Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO)

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.

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

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.

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.

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.

Proportion of subjects in which direct contact with thrombus is achieved with iNstroke 4F aspiration catheter.

Proportion of subjects achieving a modified Rankin scale (mRS) score of 0-2 at the 90-day (±14 days) post-procedure follow-up visit.

Occurrence of SICH (according to SITS-MOST (13) and ECASS criteria (14)) within 24 (-8/+12) hours post-procedure, assessed by magnetic resonance imaging (MRI)/computed tomography (CT).

Intracerebral Haemorrhage (ICH) is defined as the presence of extravascular blood in the brain or within the skull (local or remote parenchymal hematoma type 2, subarachnoid haemorrhage, and/or intraventricular haemorrhage) detected on the post-procedure imaging scan. ICH is considered symptomatic (SICH) if it is associated with a clinical deterioration, determined by a worsening/increase on the National Institutes of Health Stroke Scale (NIHSS) score of ≥4 points, or if it causes death and is identified as the predominant cause of neurological deterioration.

Occurrence of embolization in a previously non-involved (or new) territory as seen on the final control angiogram at the end of the procedure.

Occurrence of embolization in distal medium territory to the proximal occlusion as seen on the final control angiogram at the end of the procedure.

Inhospital mortality rate related to the procedure during hospital admission.

Occurrence of devices and procedure related adverse events within 90 days (±14 days) after the procedure.

Occurrence of procedure-related complications: arterial perforation, arterial dissection and severe vasospasm in the target vessel.

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.

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.

Proportion of cases in which iNstroke 4F aspiration catheter (alone or in conjunction with a SR) successfully reached the site of occlusion.

Number of passes with iNstroke 4F aspiration catheter until recanalization.

Visibility of the catheter during the thrombectomy rated from 0 to 5 (being 0 the worst and 5 the best score).

Proportion of subjects with rapid neurological improvement, defined as a decrease of more than 4 points on the NIHSS scale, during the first 24 (-8/+12) hours post-procedure.

Proportion of subjects with a reduction of ≥8 points on the NIHSS scale during the first 24 (-8/+12) hours post-procedure, or with a NIHSS score of 0-1 at 3 days (±24 hours) or at the time of discharge, whichever occurs first.

Median of NIHSS score at 24 (-8/+12) hours.

Median of NIHSS score at 3 days (±24 hours) or at the time of patient discharge, whichever occurs first.