Efficacy and Safety Evaluation of iNstroke 5F Aspiration Catheter for Thrombectomy (iNFLOW-5)

May 8, 2026 updated by: iVascular S.L.U.

Prospective, Single-arm, Multi-centre Study to Evaluate the Efficacy and Safety of the Instroke 5F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke.

Prospective, single-arm, multi-centre study to evaluate the efficacy and safety of the iNstroke 5F thromboaspiration catheter in patients with acute ischaemic stroke

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This clinical investigation has been designed to evaluate the efficacy and safety of the iNstroke 5F aspiration catheter for its use in the treatment of LVO, with a view to comparing this product with standard therapy or with other similar products in a future pivotal clinical investigation.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • CHU Bordeaux (H Pellegrin)
        • Principal Investigator:
          • Xavier Barreau, Dr.
        • Contact:
      • Lille, France
        • CHU Lille
        • Contact:
        • Principal Investigator:
          • Nicolas Bricout, Dr.
  • Spain
    • Andalusia
      • Málaga, Andalusia, Spain
        • Hospital Regional Universitario de Málaga Carlos Haya
        • Contact:
        • Principal Investigator:
          • María Teresa Díaz, Dr.
    • Aragon
      • Zaragoza, Aragon, Spain
        • Hospital Universitario Miguel Servet
        • Contact:
        • Principal Investigator:
          • María Rosa Barrena, Dr.
    • Barcelona
      • Barcelona, Barcelona, Spain
        • Hospital Clínico de Barcelona
        • Contact:
        • Principal Investigator:
          • Jordi Blasco, Dr.
    • Catalonia
      • L'Hospitalet de Llobregat, Catalonia, Spain
        • Hospital Universitario Bellvitge
    • Galicia
      • Vigo, Galicia, Spain
        • Hospital Álvaro Cunqueiro
        • Contact:
        • Principal Investigator:
          • Carlos Manuel Rodriguez, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects aged ≥ 18 years.
  • Subjects able to be treated (i.e., defined by groin puncture time) within 24 hours of symptom onset or last time seen well.
  • Occlusion in a large or proximal medium vessel (M1, proximal M2, A2 or P2) identified by magnetic resonance angiography (MRA) or computed tomography angiography (CTA).
  • Baseline NIHSS score ≥ 6 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).
  • France-specific inclusion criteria: As applicable under French law, subjects affiliated with a health social security scheme or equivalent.

Exclusion Criteria:

  • 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.
  • Women of child-bearing potential.
  • 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.
  • Subjects with cancer who have a life expectancy of less than 6 months.
  • Pre-existing neurological or psychiatric illness that could confound the neurological or functional assessments.
  • Severe sustained hypertension (systolic pressure >185 mm Hg or diastolic pressure >110 mm Hg). Note: If blood pressure can be successfully reduced and maintained at an acceptable level by administering the medication recommended by the ESO (European Stroke Organisation) in its guidelines (also IV infusion of antihypertensives), the subject may be included.
  • Known or suspected cerebral vasculitis.
  • Known renal insufficiency with creatinine ≥3 mg/dl or Glomerular Filtration Rate (GFR) <30 mL/min.
  • Current participation in an interventional drug or device study that may confound the results of this study.
  • Intracranial stenosis proximal to the occlusion.
  • France-specific exclusion criteria: As applicable under French law, breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, or persons of legal age who are the subject of a legal protection measure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Thromboaspiration using iNstroke 5F aspiration catheter
No comparator will be used as this is a traditional feasibility clinical investigation. The objective is to capture preliminary clinical performance, effectiveness and safety information to adequately plan an appropriate pivotal clinical investigation.
Device: Thromboaspiration catheter
Patients to undergo thromboaspiration with iNstroke 5F

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recanalization Rate
Time Frame: Intra-procedure
Recanalization rate with mTICI ≥2b in ≤3 revascularization passes using iNstroke Thrombus Extraction Aspiration Device aspiration catheter alone, or in conjunction with Stent Retriever
Intra-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iVascular S.L.U.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 31, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

November 30, 2027

Study Registration Dates

First Submitted

April 30, 2026

First Submitted That Met QC Criteria

April 30, 2026

First Posted (Actual)

May 7, 2026

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iNFLOW-5

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Ischemic Stroke

Clinical Trials on Thromboaspiration catheter

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe