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

NCT07357285 | Recruiting

• 1 other identifier: 4-NiVO-01
• Study Type: interventional
• Target: 57
• Locations: 3 countries
• Sites: 11

Brief 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.

Conditions

Acute Ischemic Stroke

Keywords

Stroke; Ischemia; Thromboaspiration

Outcome Measures

Primary Outcomes (1)

• Recanalization Endpoint

  Recanalization rate with a modified thrombolysis in cerebral infarction scale (mTICI) score ≥2b in ≤3 revascularization passes using iNstroke 4F aspiration catheter, alone or in conjunction with a SR.

  Intra-procedure

Secondary Outcomes (12)

• Recanalization Endpoint

  Intra-procedure

• Recanalization Endpoint

  Intra-procedure

• Recanalization Endpoint

  Intra-procedure

• Recanalization Endpoint

  Intra-procedure

• Recanalization Endpoint

  Intra-procedure

Other Outcomes (9)

• Exploratory Recanalization Endpoint

  Intra-procedure

• Exploratory Recanalization Endpoint

  Intra-procedure

• Exploratory Recanalization Endpoint

  Intra-procedure

Study Arms (1)

Thromboaspiration using iNstroke 4F aspiration catheter

OTHER

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.

Device: Thromboaspiration catheter

Interventions

Thromboaspiration catheter DEVICE

Patients to undergo thromboaspiration with iNstroke 4F

Thromboaspiration using iNstroke 4F aspiration catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 with pre-existing neurological or psychiatric illness that could confound the neurological or functional assessments.

Sponsors & Collaborators

• iVascular S.L.U.: lead

Study Sites (11)

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

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: January 22, 2026
• Study Start: November 27, 2025
• Primary Completion: May 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5); HU (1); ES (5)