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.
This study is an exploratory, interventional, open label, single-arm, multi-centre prospective clinical investigation. In this post-market clinical investigation, the aim is to further evaluate the efficacy and safety of the iNstroke 4F aspiration catheter, with a view to, in future clinical investigations, comparing the product with the standard therapy or with other similar products. In addition, this clinical investigation will generate results that could be used to further assess the safety and effectiveness of mechanical thrombectomy for the treatment of DMVO.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
57
Patients to undergo thromboaspiration with iNstroke 4F
Universitätsklinikum Bonn
Bonn, Germany
NOT_YET_RECRUITINGUniversitätsklinikum Schleswig-Holstein
Kiel, Germany
NOT_YET_RECRUITINGKlinikum Marburg
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.
Time frame: Intra-procedure
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
Time frame: Intra-procedure
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.
Time frame: Intra-procedure
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.
Time frame: Intra-procedure
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.
Time frame: Intra-procedure
Recanalization Endpoint
Proportion of subjects in which direct contact with thrombus is achieved with iNstroke 4F aspiration catheter.
Time frame: Intra-procedure
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Marburg, Germany
Klinikum Nürnberg
Nuremberg, Germany
NOT_YET_RECRUITINGKnappschaftskrankenhaus Recklinghausen
Recklinghausen, Germany
RECRUITINGSemmelweis University Center
Budapest, Hungary
RECRUITINGHospital Universitario Vall d'Hebron
Barcelona, Spain
RECRUITINGHospital Universitario 12 de Octubre
Madrid, Spain
NOT_YET_RECRUITINGHospital Universitario de Getafe
Madrid, Spain
NOT_YET_RECRUITINGHospital Universitario La Paz
Madrid, Spain
NOT_YET_RECRUITING...and 1 more locations
Clinical Endpoint
Proportion of subjects achieving a modified Rankin scale (mRS) score of 0-2 at the 90-day (±14 days) post-procedure follow-up visit.
Time frame: 90 day
Safety Endpoint
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.
Time frame: 24 (-8/+12) hours
Safety Endpoint
Occurrence of embolization in a previously non-involved (or new) territory as seen on the final control angiogram at the end of the procedure.
Time frame: Intra-procedure
Safety Endpoint
Occurrence of embolization in distal medium territory to the proximal occlusion as seen on the final control angiogram at the end of the procedure.
Time frame: Intra-procedure
Safety Endpoint
Inhospital mortality rate related to the procedure during hospital admission.
Time frame: During hospital admission
Safety Endpoint
Occurrence of devices and procedure related adverse events within 90 days (±14 days) after the procedure.
Time frame: 90 days (±14 days) after the procedure.
Safety Endpoint
Occurrence of procedure-related complications: arterial perforation, arterial dissection and severe vasospasm in the target vessel.
Time frame: Intra-procedure