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)

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).

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Device: Thromboaspiration catheter

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bonn, Germany
    • Not yet recruiting
    • Universitätsklinikum Bonn
    • Contact: Franziska Dorn; Phone Number: +34 936724711; Email: clinica@ivascular.global
    • Principal Investigator: Franziska Dorn, Prof.
  • Kiel, Germany
    • Not yet recruiting
    • Universitätsklinikum Schleswig-Holstein
    • Principal Investigator: Peter Schramm
    • Contact: Peter Schramm; Phone Number: +34 936724711; Email: clinica@ivascular.global
  • Marburg, Germany
    • Not yet recruiting
    • Klinikum Marburg
    • Contact: André Kemmling; Phone Number: +34 936724711; Email: clinica@ivascular.global
    • Principal Investigator: André Kemmling, Prof. Dr.
  • Nuremberg, Germany
    • Not yet recruiting
    • Klinikum Nürnberg
    • Contact: Markus Holtmannspötter; Phone Number: +34 936724711; Email: clinica@ivascular.global
    • Principal Investigator: Markus Holtmannspötter, Prof. Dr.
  • Recklinghausen, Germany
    • Recruiting
    • Knappschaftskrankenhaus Recklinghausen
    • Contact: Christian Loehr; Phone Number: +34 936724711; Email: clinica@ivascular.global
    • Principal Investigator: Christian Loehr, Dr.
• Hungary
  • Budapest, Hungary
    • Recruiting
    • Semmelweis University Center
    • Contact: Sandor Nardai; Phone Number: +34 936724711; Email: clinica@ivascular.global
    • Principal Investigator: Sandor Nardai, Dr.
• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital Universitario Vall d'Hebron
    • Contact: Manuel Requena; Phone Number: +34 936724711; Email: clinica@ivascular.global
    • Principal Investigator: Manuel Requena, Dr.
  • Madrid, Spain
    • Not yet recruiting
    • Hospital Universitario 12 de Octubre
    • Contact: José Manuel Muñoz; Phone Number: +34 936724711; Email: clinica@ivascular.global
    • Principal Investigator: José Manuel Muñoz, Dr.
  • Madrid, Spain
    • Not yet recruiting
    • Hospital Universitario La Paz
    • Contact: Pedro Navia; Phone Number: +34 936724711; Email: clinica@ivascular.global
    • Principal Investigator: Pedro Navia, Dr.
  • Madrid, Spain
    • Not yet recruiting
    • Hospital Universitario de Getafe
    • Contact: José Manuel Muñoz; Phone Number: +34 936724711; Email: clinica@ivascular.global
    • Principal Investigator: José Manuel Muñoz, Dr.
  • Murcia, Spain
    • Recruiting
    • Hospital Clínico Universitario Virgen de Arrixaca
    • Contact: Joaquin Zamarro; Phone Number: +34 936724711; Email: clinica@ivascular.global
    • Principal Investigator: Joaquin Zamarro, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Thromboaspiration using iNstroke 4F aspiration catheter; 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; Patients to undergo thromboaspiration with iNstroke 4F

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recanalization Endpoint	Proportion of subjects treated with iNstroke 4F alone with complete recanalization in primary DMVO defined as an mTICI ≥2b, after iNstroke 4F aspiration catheter alone (ADAPT) was used as a first-line therapy	Intra-procedure
Recanalization Endpoint	Proportion of subjects treated with iNstroke 4F in conjunction with a stent retriever having complete recanalization in primary DMVO defined as achieving an mTICI ≥2b, after iNstroke 4F aspiration catheter, in conjunction with a stent retriever (SR), was used as a first-line therapy.	Intra-procedure
Recanalization Endpoint	Proportion of subjects with mTICI≥2b, mTICI≥2c and mTICI 3 after first pass with iNstroke 4F aspiration catheter used both alone and in conjunction with a SR.	Intra-procedure
Recanalization Endpoint	Time from groin puncture to achievement of complete recanalization (mTICI ≥2b), or if not achieved, until the final angiogram time, in patients treated with iNstroke 4F aspiration catheter, alone or in conjunction with a SR, as a first-line therapy.	Intra-procedure
Recanalization Endpoint	Proportion of subjects in which direct contact with thrombus is achieved with iNstroke 4F aspiration catheter.	Intra-procedure
Clinical Endpoint	Proportion of subjects achieving a modified Rankin scale (mRS) score of 0-2 at the 90-day (±14 days) post-procedure follow-up visit.	90 day
Safety Endpoint	Occurrence of SICH (according to SITS-MOST (13) and ECASS criteria (14)) within 24 (-8/+12) hours post-procedure, assessed by magnetic resonance imaging (MRI)/computed tomography (CT). Intracerebral Haemorrhage (ICH) is defined as the presence of extravascular blood in the brain or within the skull (local or remote parenchymal hematoma type 2, subarachnoid haemorrhage, and/or intraventricular haemorrhage) detected on the post-procedure imaging scan. ICH is considered symptomatic (SICH) if it is associated with a clinical deterioration, determined by a worsening/increase on the National Institutes of Health Stroke Scale (NIHSS) score of ≥4 points, or if it causes death and is identified as the predominant cause of neurological deterioration.	24 (-8/+12) hours
Safety Endpoint	Occurrence of embolization in a previously non-involved (or new) territory as seen on the final control angiogram at the end of the procedure.	Intra-procedure
Safety Endpoint	Occurrence of embolization in distal medium territory to the proximal occlusion as seen on the final control angiogram at the end of the procedure.	Intra-procedure
Safety Endpoint	Inhospital mortality rate related to the procedure during hospital admission.	During hospital admission
Safety Endpoint	Occurrence of devices and procedure related adverse events within 90 days (±14 days) after the procedure.	90 days (±14 days) after the procedure.
Safety Endpoint	Occurrence of procedure-related complications: arterial perforation, arterial dissection and severe vasospasm in the target vessel.	Intra-procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Recanalization Endpoint	Proportion of subjects in which a switch of technique (from ADAPT to combined or from combined to ADAPT) with iNstroke 4F aspiration catheter was used to successfully perform the thrombectomy.	Intra-procedure
Exploratory Recanalization Endpoint	Proportion of subjects in which an aspiration catheter device with a 4F caliber different from iNstroke 4F aspiration catheter was used as a rescue therapy.	Intra-procedure
Exploratory Recanalization Endpoint	Proportion of cases in which iNstroke 4F aspiration catheter (alone or in conjunction with a SR) successfully reached the site of occlusion.	Intra-procedure
Exploratory Recanalization Endpoint	Number of passes with iNstroke 4F aspiration catheter until recanalization.	Intra-procedure
Exploratory Recanalization Endpoint	Visibility of the catheter during the thrombectomy rated from 0 to 5 (being 0 the worst and 5 the best score).	Intra-procedure
Exploratory Clinical Endpoint	Proportion of subjects with rapid neurological improvement, defined as a decrease of more than 4 points on the NIHSS scale, during the first 24 (-8/+12) hours post-procedure.	24 (-8/+12) hours post-procedure.
Exploratory Clinical Endpoint	Proportion of subjects with a reduction of ≥8 points on the NIHSS scale during the first 24 (-8/+12) hours post-procedure, or with a NIHSS score of 0-1 at 3 days (±24 hours) or at the time of discharge, whichever occurs first.	First 24 (-8/+12) hours post-procedure or 3 days (±24 hours) or at the time of discharge, whichever occurs first.
Exploratory Clinical Endpoint	Median of NIHSS score at 24 (-8/+12) hours.	24 (-8/+12) hours.
Exploratory Clinical Endpoint	Median of NIHSS score at 3 days (±24 hours) or at the time of patient discharge, whichever occurs first.	3 days (±24 hours) post procedure

Collaborators and Investigators

• Sponsor: iVascular S.L.U.

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Stroke; Ischemia; Thromboaspiration
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemic Stroke; Stroke; Ischemia
• Other Study ID Numbers: 4-NiVO-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No