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

iVascular

Status: Enrolling

Conditions: Acute Ischemic Stroke

Treatments: Device: Thromboaspiration catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT07357285

4-NiVO-01

Details and patient eligibility

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.

Full description

This study is an exploratory, interventional, open label, single-arm, multi-centre prospective clinical investigation.

In this post-market clinical investigation, the aim is to further evaluate the efficacy and safety of the iNstroke 4F aspiration catheter, with a view to, in future clinical investigations, comparing the product with the standard therapy or with other similar products. In addition, this clinical investigation will generate results that could be used to further assess the safety and effectiveness of mechanical thrombectomy for the treatment of DMVO.

Enrollment: 57 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

Thromboaspiration using iNstroke 4F aspiration catheter

Other group

Description:

No comparator will be used in this clinical investigation as it is an exploratory study of a CE-marked medical device to be used within the scope of its intended purpose.

Treatment:

Device: Thromboaspiration catheter