Actively Recruiting
Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO)
Led by iVascular S.L.U. · Updated on 2026-01-23
57
Participants Needed
11
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Universitätsklinikum Bonn
Bonn, Germany
Not Yet Recruiting
2
Universitätsklinikum Schleswig-Holstein
Kiel, Germany
Not Yet Recruiting
3
Klinikum Marburg
Marburg, Germany
Not Yet Recruiting
4
Klinikum Nürnberg
Nuremberg, Germany
Not Yet Recruiting
5
Knappschaftskrankenhaus Recklinghausen
Recklinghausen, Germany
Actively Recruiting
6
Semmelweis University Center
Budapest, Hungary
Actively Recruiting
7
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Actively Recruiting
8
Hospital Universitario 12 de Octubre
Madrid, Spain
Not Yet Recruiting
9
Hospital Universitario de Getafe
Madrid, Spain
Not Yet Recruiting
10
Hospital Universitario La Paz
Madrid, Spain
Not Yet Recruiting
11
Hospital Clínico Universitario Virgen de Arrixaca
Murcia, Spain
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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