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

Recruiting now · Not applicable

Conditions studied: Acute Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT07357285

Run by

iVascular S.L.U.

People needed

57

Starts

2025-11-27

Expected to finish

2026-08-31

Last updated by the study team

2026-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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 petrous segment of the internal carotid artery).
• Subjects with occlusions in multiple vessels (e.g., MCA-M3 and ACA-A2), whether or not they undergo mechanical thrombectomy.
• Subjects with cancer (with or without metastases) who have a life expectancy of less than 6 months.
• Subjects participating in a clinical trial at the moment of the inclusion.
• Subjects with pre-existing neurological or psychiatric illness that could confound the neurological or functional assessments.

Where it is running

• Hospital Clínico Universitario Virgen de Arrixaca — Murcia, Spain (enrolling)
• Knappschaftskrankenhaus Recklinghausen — Recklinghausen, Germany (enrolling)
• Semmelweis University Center — Budapest, Hungary (enrolling)
• Hospital Universitario Vall d'Hebron — Barcelona, Spain (enrolling)
• Hospital Universitario de Getafe — Madrid, Spain
• Hospital Universitario La Paz — Madrid, Spain
• Universitätsklinikum Bonn — Bonn, Germany
• Hospital Universitario 12 de Octubre — Madrid, Spain
• Universitätsklinikum Schleswig-Holstein — Kiel, Germany
• Klinikum Marburg — Marburg, Germany
• Klinikum Nürnberg — Nuremberg, Germany

Full record on ClinicalTrials.gov

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