Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO)
Recruiting
N/AInterventional Study
Acute Ischemic Stroke
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
57 (estimated)
Sponsor
iVascular S.L.U. · Industry
Who this trial is looking for
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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.
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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 mag…
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.
Contacts
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