Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO)
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: Thromboaspiration catheter.
- Who it may be relevant to
- Registry conditions: Acute Ischemic Stroke. Basic parameters: from 18 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
- Germany, Hungary, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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 (DMVO).
Overview
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
- Device Thromboaspiration catheter
Patients to undergo thromboaspiration with iNstroke 4F
Primary outcome measures
- Recanalization Endpoint [Time frame: Intra-procedure]
Secondary outcome measures (12)
- Recanalization Endpoint [Time frame: Intra-procedure]
- Recanalization Endpoint [Time frame: Intra-procedure]
- Recanalization Endpoint [Time frame: Intra-procedure]
- Recanalization Endpoint [Time frame: Intra-procedure]
- Recanalization Endpoint [Time frame: Intra-procedure]
- Clinical Endpoint [Time frame: 90 day]
- Safety Endpoint [Time frame: 24 (-8/+12) hours]
- Safety Endpoint [Time frame: Intra-procedure]
- Safety Endpoint [Time frame: Intra-procedure]
- Safety Endpoint [Time frame: During hospital admission]
- Safety Endpoint [Time frame: 90 days (±14 days) after the procedure.]
- Safety Endpoint [Time frame: Intra-procedure]
Eligibility criteria
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.
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
Germany · 5 centers
- Universitätsklinikum Bonn — Bonn
- Universitätsklinikum Schleswig-Holstein — Kiel
- Klinikum Marburg — Marburg
- Klinikum Nürnberg — Nuremberg
- Knappschaftskrankenhaus Recklinghausen — Recklinghausen
Spain · 5 centers
- Hospital Universitario Vall d'Hebron — Barcelona
- Hospital Universitario 12 de Octubre — Madrid
- Hospital Universitario de Getafe — Madrid
- Hospital Universitario La Paz — Madrid
- Hospital Clínico Universitario Virgen de Arrixaca — Murcia
Hungary · 1 center
- Semmelweis University Center — Budapest
Identifiers
NCT: NCT07357285 · 4-NiVO-01