Evaluation of iNstroke Aspiration Catheters for Thrombectomy: a Multi-center Prospective Study (iNDUO)

January 29, 2026 updated by: iVascular S.L.U.

Confirmation of the Performance and Safety of the iNstroke 6F and 4F Thromboaspiration Catheter for the Treatment of Acute Ischemic Stroke

Prospective, single-arm, multi-center study to confirm the performance and safety of the iNstroke 6F and 4F thromboaspiration catheter for the treatment of acute ischemic stroke

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This clinical investigation has been designed to generate further data demonstrating the safety and effectiveness of the iNstroke device as well as of the thrombectomy process for the treatment of large and medium vessel occlusions.

Study Type

Interventional

Enrollment (Estimated)

160

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)
        • Contact:
        • Principal Investigator:
          • Xavier Barreau, Dr.
      • Brest, France
        • CHU Brest
        • Contact:
        • Principal Investigator:
          • Jean Christoph Gentric, Dr.
      • Lille, France
        • CHU Lille
        • Contact:
        • Principal Investigator:
          • Nicolas Bricout, Dr.
      • Nancy, France
        • CHU Nancy
        • Contact:
        • Principal Investigator:
          • Benjamin Gory, Dr.
      • Paris, France
        • APHP Pitié Salpétrière
        • Contact:
        • Principal Investigator:
          • Frédéric Clarencon, Dr.
      • Strasbourg, France
        • CHU Strasbourg
        • Principal Investigator:
          • Frédéric Clarencon, Dr.
        • Contact:
  • Germany
      • Bremen, Germany
        • Klinikum Bremen Mitte
        • Contact:
        • Principal Investigator:
          • Panagiotis Papanagiotou, Dr.
      • Cologne, Germany
        • Universität zu Köln
        • Contact:
        • Principal Investigator:
          • Christoph Kabbasch, Dr.
      • Dortmund, Germany
        • Knappschaft Kliniken
        • Contact:
        • Principal Investigator:
          • Jens Altenbernd, Dr.
      • Hamburg, Germany
        • UKE Hamburg
        • Contact:
        • Principal Investigator:
          • Fabian Flottmann, Dr.
      • Nuremberg, Germany
        • Klinikum Nürnberg
        • Contact:
        • Principal Investigator:
          • Markus Holtmannspötter, Prof. 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:

  1. Patients ≥ 18 years of age.
  2. Able to be treated (i.e., defined by arterial puncture time) within 24 hours of symptom onset or last time seen well (LTSW).
  3. Demonstrated occlusion in a large and/or medium vessel (carotid T, M1, proximal M2, M2-M3, A1, A2, A3, basilar artery, P1, P2, P3).
  4. Baseline NIHSS score ≥6 assessed before the procedure.
  5. Pre-morbid [xB13.1]stroke baseline mRS ≤ 2.
  6. Subjects with an ASPECTS ≥ 6.
  7. Informed consent signed by the subject or their representative, or notice of information, as per regulatory requirements, to collect the subject's data.
  8. As applicable by French laws, the subject is affiliated to a health social security regimen or equivalent (only to be answered by French sites).

Exclusion Criteria:

  1. 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.
  2. Severe allergy to contrast media.
  3. As applicable by French laws: breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, or persons of full age who are the subject of a legal protection measure.
  4. Patients with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection.
  5. Multiple Intracranial Occlusions
  6. Known medical history of thrombocytopenia (Platelets <100,000).
  7. Presence of intracerebral hemorrhage.
  8. Significant mass effect and/or midline shift.
  9. Evidence of intracranial tumor (except small meningioma).
  10. Intracranial stenosis proximal to the occlusion.
  11. 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 patient may be included.
  12. Known or suspected cerebral vasculitis.
  13. Known renal insufficiency with creatinine ≥3 mg/dl or Glomerular Filtration Rate (GFR) <30 mL/min.
  14. Current participation in an interventional drug or device study that may confound the results of this study.

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 4F and/or iNstroke 6F 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 6F and/or 4F

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)

May 31, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 22, 2026

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iNDUO-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

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.

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