Efficacy and Safety Evaluation of iNstroke 5F Aspiration Catheter for Thrombectomy
ConditionAcute Ischemic Stroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsoriVascular S.L.U.
About this trial
Prospective, single-arm, multi-centre study to evaluate the efficacy and safety of the iNstroke 5F thromboaspiration catheter in patients with acute ischaemic stroke
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects aged ≥ 18 years.
Subjects able to be treated (i.e., defined by groin puncture time) within 24 hours of symptom onset or last time seen well.
Occlusion in a large or proximal medium vessel (M1, proximal M2, A2 or P2) identified by magnetic resonance angiography (MRA) or computed tomography angiography (CTA).
Baseline NIHSS score ≥ 6 assessed before the procedure.
Disqualifiers
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.
Women of child-bearing potential.
Subjects with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection.
Trial design
Design model
Single group
Treatments tested in this trial
Thromboaspiration catheter
DevicePatients to undergo thromboaspiration with iNstroke 5F
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: Thromboaspiration using iNstroke 5F aspiration catheterOther 1 intervention
Trial outcomes
Primary outcomes
1
Recanalization Rate
Recanalization rate with mTICI ≥2b in ≤3 revascularization passes using iNstroke Thrombus Extraction Aspiration Device aspiration catheter alone, or in conjunction with Stent Retriever
Time frame
Intra-procedureSponsors and contacts
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Source ClinicalTrials.gov
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