iNstroke 4F catheter for removing clots in distal medium-vessel ischemic stroke
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 (DMVO).
This trial will test whether the iNstroke 4F thromboaspiration catheter can safely remove clots and improve outcomes for adults with acute ischemic stroke caused by distal medium vessel occlusions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 57 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | iVascular S.L.U. Industry-sponsored |
| Locations | 11 sites (Bonn and 10 other locations) |
| Trial ID | NCT07357285 on ClinicalTrials.gov |
What this trial studies
This is a prospective, open-label, single-arm, multi-centre post-market clinical investigation of the iNstroke 4F aspiration catheter in adults with primary distal medium vessel occlusions (DMVO). Eligible patients present within 24 hours of symptom onset with occlusions in distal MCA (M2–M4), ACA (A2–A3) or PCA (P1–P3) segments, baseline NIHSS ≥5, ASPECTS ≥6 and pre-stroke mRS ≤2. Enrolled patients will undergo thromboaspiration with the iNstroke 4F device and be followed for procedural safety, rates of recanalization, and clinical outcomes. The single-arm design aims to generate safety and effectiveness data to inform future comparative trials and broader use of mechanical thrombectomy for DMVO.
Who should consider this trial
Good fit: Adults aged 18 or older with acute ischemic stroke due to a primary distal medium vessel occlusion identified by CTA or MRA, presenting within 24 hours, with NIHSS ≥5, ASPECTS ≥6, and pre-stroke mRS ≤2 are ideal candidates.
Not a fit: Patients with suspected secondary DMVO, evidence of primary large vessel occlusion, baseline NIHSS <5, pre-stroke mRS >2, ASPECTS <6, or those presenting outside the 24-hour window are unlikely to benefit from this intervention in this study.
Why it matters
Potential benefit: If successful, the device could increase clot removal success and improve functional outcomes for patients with distal medium-vessel strokes using a smaller, more navigable aspiration catheter.
How similar studies have performed: Mechanical thrombectomy is well established for large vessel occlusion but evidence for aspiration or thrombectomy specifically in distal medium vessel occlusions is limited to small series and exploratory studies, so this approach remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 \<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 this trial is running
Bonn and 10 other locations
- Universitätsklinikum Bonn — Bonn, Germany (Not_yet_recruiting)
- Universitätsklinikum Schleswig-Holstein — Kiel, Germany (Not_yet_recruiting)
- Klinikum Marburg — Marburg, Germany (Not_yet_recruiting)
- Klinikum Nürnberg — Nuremberg, Germany (Not_yet_recruiting)
- Knappschaftskrankenhaus Recklinghausen — Recklinghausen, Germany (Recruiting)
- Semmelweis University Center — Budapest, Hungary (Recruiting)
- Hospital Universitario Vall d'Hebron — Barcelona, Spain (Recruiting)
- Hospital Universitario 12 de Octubre — Madrid, Spain (Not_yet_recruiting)
- Hospital Universitario de Getafe — Madrid, Spain (Not_yet_recruiting)
- Hospital Universitario La Paz — Madrid, Spain (Not_yet_recruiting)
- Hospital Clínico Universitario Virgen de Arrixaca — Murcia, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.