Acute Ischemic Stroke
Conditions
Keywords
Stroke, Ischemia, Thromboaspiration
Brief summary
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.
Detailed description
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.
Interventions
Patients to undergo thromboaspiration with iNstroke 4F
Sponsors
iVascular S.L.U.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * Pre-stroke mRS score ≤ 2. * Subjects with an ASPECTS score ≥ 6. * Informed consent obtained in accordance with the applicable country-specific regulations and as approved by the Ethics Committee (EC).
Exclusion criteria
* 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. * Subjects with an ASPECTS score \<6. * Severe comorbidity and/or shortened life expectancy that will likely prevent improvement or follow up or that will render the procedure unlikely to benefit the patient. * Severe allergy to contrast media. * Subjects with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection. * Medical history of thrombocytopenia (Platelets \<100,000). * Subjects with tandem occlusions (evidence of complete occlusion, high-grade stenosis or arterial dissection in the extracranial or petrous segment of the internal carotid artery). * Subjects with occlusions in multiple vessels (e.g., MCA-M3 and ACA-A2), whether or not they undergo mechanical thrombectomy. * Subjects with cancer (with or without metastases) who have a life expectancy of less than 6 months. * Subjects participating in a clinical trial at the moment of the inclusion. * Subjects with pre-existing neurological or psychiatric illness that could confound the neurological or functional assessments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recanalization Endpoint | Intra-procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recanalization Endpoint | Intra-procedure | 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 |
| Clinical Endpoint | 90 day | Proportion of subjects achieving a modified Rankin scale (mRS) score of 0-2 at the 90-day (±14 days) post-procedure follow-up visit. |
| Safety Endpoint | 24 (-8/+12) hours | 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. |
Countries
Germany, Hungary, Spain
Outcome results
None listed