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Active Not Recruiting
NCT07357285
Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO)
Conditions: Acute Ischemic Stroke
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 57
Sponsor: iVascular S.L.U.
Location: Universitätsklinikum Bonn Bonn
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.
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 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 \2.
* Subjects with an ASPECTS score \
Source: ClinicalTrials.gov (NCT07357285). StuddyBuddy aggregates publicly available trial information.