Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO)

Trial statusRecruiting
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 4F Thromboaspiration Catheter in Patients with Acute Ischaemic Stroke due to Primary Distal Medium Vessel Occlusions.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Thromboaspiration catheter

Treatment groups

57 Participants
are divided into 1 treatment group

Sponsors and collaborators