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
Qualifiers
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
Treatments tested in this trial
- Thromboaspiration catheter
Treatment groups
45 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov