Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acu… (NCT07357285) | Clinical Trial Compass
RecruitingNot Applicable
Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO)
Germany57 participantsStarted 2025-11-27
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 petro…